ClinicalTrials.gov record NCT07093333

A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase 2a, Open-label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of ART5803 in Participants With Anti-NMDAR Encephalitis and AntiNMDAR Autoantibody-Associated Psychiatric Disease

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age19 years old to 65 years old
SexAll
LocationSouth Korea
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2a, open‑label, non‑randomized study gives ART5803 by intravenous infusion to adults with confirmed anti‑NMDAR encephalitis or anti‑NMDAR autoantibody‑associated psychiatric disease. Participants are assigned to cohorts for chronic, subacute, acute ANRE, or antibody‑associated psychiatric disease. The study monitors safety, drug levels in blood and cerebrospinal fluid, and clinical measures over about 26 weeks. Dosing starts with sentinel participants (30 mg/kg) and subsequent participants may receive up to 60 mg/kg, given weekly for 4 doses then every 2 weeks for 4 doses.

What it is studying. The study tests whether ART5803 can be given safely and tolerated in adults with anti‑NMDAR conditions, and collects early data on how the drug behaves in the body (pharmacokinetics) and on clinical measures of neurological and psychiatric status. ART5803 is a one‑armed antibody designed to bind the NMDAR NR1 subunit and block pathogenic anti‑NMDAR autoantibodies without causing receptor internalization, per the registry description.

What the researchers hope to learn. To evaluate the safety and tolerability of ART5803, describe its pharmacokinetic profile in serum and cerebrospinal fluid, and collect preliminary data on clinical and neuropsychological outcomes in people with anti‑NMDAR encephalitis or anti‑NMDAR autoantibody‑associated psychiatric disease.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study will evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics (PK) of ART5803 in adult participants with a confirmed diagnosis of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis (ANRE) or anti-NMDAR autoantibody-associated psychiatric disease

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • ART5803
  • ART5803-Cohort D

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 3.1 Inclusion Criteria Individuals in Cohort A (participants with chronic ANRE) must meet all of the study inclusion criteria in Section 7.3.1.1. Individuals enrolled in Cohort B or Cohort C (participants with subacute or acute ANRE) must meet all of the study inclusion criteria in Section 7.3.1.2. Individuals in Cohort D (participants with anti-NMDAR autoantibody associated psychiatric disease) must meet all of the study inclusion criteria in Section 7.3.1.3.
  • Eligibility for participation in this study will be determined solely based on the participant meeting all protocol-defined inclusion and

Exclusion criteria

  • . The legally authorized representative (LAR), where applicable, may provide informed consent on behalf of a participant who lacks the capacity to provide consent in accordance with local regulations; however, the LAR does not independently satisfy eligibility criteria. A participant who does not meet all required inclusion and exclusion criteria will not be enrolled in the study, regardless of the availability or status of an LAR.
  • 3.1.1 Cohort A Inclusion Criteria The criteria below must be applied to all participants screened for Cohort A (participants with chronic ANRE) of the study.
  • Individuals eligible to participate in Cohort A must meet all the following criteria:
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.
  • The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset >9 months to ≤36 months (or ≤120 months with Sponsor approval) prior to Week 0, Day 0.
  • The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months of Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months of Week 0, Day 0 may undergo a LP at Screening prior to the first study drug administration to confirm the presence of anti-NMDAR IgG autoantibodies in CSF (see Section 7.6.4.6.1).
  • Note: If the participant has a documented history of positive anti-NMDAR IgG autoantibodies in CSF >9 months of Week 0, Day 0, they may be considered for inclusion in the study with confirmed positive anti-NMDAR IgG autoantibodies in serum at Screening at the discretion of the Investigator in collaboration with the Sponsor (see Section 7.6.4.6.1).
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Participants who are taking psychiatric medications (anti-depressants and antipsychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.
  • Adequate disease burden as defined as any one of the following (a to c) at Screening and Week 0, Day 0:
  • a. Two of the following: i. WAIS-IV immediate recall score <7 ii. TMT-A >40 seconds iii. RAVLT score <7 b. BDI-II total score ≥20. c. EQ 5D-5L score "moderate" or higher on at least 3 of the 5 items. Exceptions may be granted on a case-by-case basis in consultation with the Sponsor.
  • No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers).
  • Note: Discovery of a contralateral teratoma after study initiation will not be considered a protocol deviation. The event must be reported, managed per standard of care, and reviewed with the Sponsor Medical Monitor.
  • Participants must have undergone appropriate cancer screening prior to study enrollment. The specific series of investigations used for each participant will occur according to the judgment of the treating Investigator (for example, MRI or CT of the chest, abdomen, and pelvis, and pelvic ultrasound for female participants) to exclude the presence or recurrence of an underlying neoplasm, such as ovarian teratoma or other malignancy. Documentation of imaging results must be available in the source documents.
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.
  • In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 follicle stimulating hormone [FSH] measurement of at least >40 IU/L [or higher per local institutional guidelines]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).
  • Male participants must agree not to donate sperm, and female participants must agree not to donate eggs from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.
  • In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study.
  • 3.1.2 Cohort B and Cohort C Inclusion Criteria The criteria below must be applied to all participants screened for Cohort B (participants with subacute ANRE) or Cohort C (participants with acute ANRE) of the study.
  • Individuals eligible to participate in Cohort B or C must meet all of the following criteria:
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.
  • The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset ≥4 months and ≤9 months (Cohort B) or ≥0 months and <4 months (Cohort C) prior to Week 0, Day 0.
  • Participants with ANRE symptoms as assessed by the mRS with a score of ≥3 during Screening and Week 0, Day 0.
  • The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months for Cohort B and 4 months for Cohort C prior to Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months for Cohort B and 4 months for Cohort C of Week 0, Day 0 may undergo a LP at Screening prior to the first study drug administration to confirm the presence of anti-NMDAR IgG autoantibodies in CSF (see Section 7.6.4.6.1).
  • Note: If the participant documented history of positive anti-NMDAR IgG autoantibodies in CSF >9 months for Cohort B and >4 months for Cohort C, they may be considered for inclusion in the study with confirmed positive anti-NMDAR IgG autoantibodies in serum at Screening at the discretion of the Investigator in collaboration with the Sponsor (see Section 7.6.4.6.1).
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Immunotherapy:
  • Cohort B: Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Cohort C: Participants may receive ART5803 regardless of previous or ongoing immunotherapy treatment status (per the Investigator's discretion).
  • Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.
  • Participants treated with plasmapheresis must have completed treatment at least 1 day prior to Week 0, Day 0.
  • Participants receiving steroids must be on a stable dose or a predefined taper regimen for at least 2 weeks prior to Week 0, Day 0.
  • No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers).
  • Note: Discovery of a contralateral teratoma after study initiation will not be considered a protocol deviation. The event must be reported, managed per standard of care, and reviewed with the Sponsor Medical Monitor.
  • Participants must have undergone appropriate cancer screening prior to study enrollment. The specific series of investigations used for each participant will occur according to the judgment of the treating Investigator (for example, MRI or CT of the chest, abdomen, and pelvis, and pelvic ultrasound for female participants) to exclude the presence or recurrence of an underlying neoplasm, such as ovarian teratoma or other malignancy. Documentation of imaging results must be available in the source documents.
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.
  • In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 FSH measurement of at least >40 IU/L [or higher per local institutional guidelines]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).
  • Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.
  • In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study.
  • 3.1.3 Cohort D Inclusion Criteria The criteria below must be applied to all participants screened for Cohort D (participants with anti-NMDAR autoantibody-associated psychiatric disease) of the study.
  • Individuals eligible to participate in Cohort D must meet all of the following criteria:
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.
  • The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has persistent psychotic symptoms for at least 2 months prior to Screening and Week 0, Day 0 as evaluated by the Investigator.
  • The participant has marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
  • The participant has the documented presence of:
  • Anti-NMDAR autoantibodies in CSF within 6 months of Week 0, Day 0; or
  • Positive CSF anti-NMDAR autoantibody within 12 months of Week 0, Day 0 and positive serum anti-NMDAR autoantibody during Screening (see Section 7.6.4.6.1).
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.
  • Adequate disease burden as defined as both of the following:
  • a. Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥70 and a PANSS item score ≥4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, suspiciousness, and unusual thought content at Screening and Week 0, Day 0.
  • Exceptions may be granted on a case-by-case basis in consultation with the Sponsor.
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.
  • In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 FSH measurement of at least >40 IU/L [or higher per local institutional guidelines]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).
  • Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.
  • In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study.
  • 3.2 Exclusion Criteria Individuals (Cohorts A, B, C, or D) will not be eligible to participate in the study if they meet any of the exclusion criteria.
  • The participant is pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
  • The participant has used an investigational product (IP) or investigational medical device within 30 days or 5 half-lives of the other IP (whichever is longer) prior to Screening or is required to use any investigational agent prior to completion of all scheduled study assessments.
  • The participant has used an NMDAR modulator other than the study drug (e.g., ketamine, memantine, dextromethorphan, amantadine, ifenprodil, phencyclidine, acamprosate, D-cycloserine) from within 5 half-lives of the NMDAR modulator prior to Week 0, Day 0.
  • The participant has previous exposure to ART5803 or other antibody that targets NMDAR.
  • Participant has any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk.
  • Participant with coexisting CNS demyelinating disorders (e.g., multiple sclerosis), known positivity to other autoantibodies associated with autoimmune encephalitis, or any significant history of a psychiatric or neurologic disorder other than ANRE should undergo consultation with the Sponsor Medical Monitor on a case-by-case basis for eligibility determination. MOG antibody positivity may be permitted on a case-by-case basis if the condition is clinically inactive and not expected to confound study assessments.
  • The participant has a confirmed positive test for hepatitis B serology (hepatitis B surface antigen and core antigen) and/or hepatitis C polymerase chain reaction at Screening.
  • The participant has a known history of allergy or reaction to any component of the investigational agent (ART5803), or history of anaphylaxis following any biologic therapy.
  • The participant has a history (within 12 months prior to Screening for Cohorts A, B, or C) or current (for Cohort D) alcohol abuse or drug addiction, defined as moderate or severe substance use disorder per Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition, or any pattern of alcohol or substance use that, in the Investigator's judgment and after discussion with the

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is one of the most common causes of autoimmune encephalitis. The disease is caused by the development of autoantibodies against the amino (N)-terminal domain (NTD) of the NMDAR subunit 1 (NR1) that bind and cross link the receptors, leading to receptor internalization and loss of function. Arialys has developed a monovalent (one-armed) antibody, ART5803, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor. There is also an increasing body of data supporting the potential link between broader psychiatric diseases and the presence of autoantibodies against the NMDAR.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive repeated intravenous infusions of ART5803 (sentinel lower‑dose participants then subsequent dosing up to a higher dose) over a series of 8 doses (weekly for 4 doses, then every 2 weeks for 4 doses). Study visits include safety monitoring (physical and neurological exams, vital signs, blood tests, ECGs), antibody and drug level testing in blood and possibly cerebrospinal fluid, neuropsychological tests and questionnaires, and regular follow‑up visits over the study period (safety and outcomes are assessed up to about 26 weeks). A lumbar puncture (spinal tap) may be done at Screening or during the study to confirm CSF antibodies and for CSF drug measurements.

How the study is structured. Interventional, open‑label Phase 2a study with one treatment group and no masking. Participants receive IV infusions of ART5803 (sentinel dosing then higher doses as allowed) given once weekly for 4 weeks then every 2 weeks for 8 weeks (8 total doses). The study includes safety monitoring (adverse events, exams, labs, ECG), blood pharmacokinetic sampling, possible lumbar puncture for CSF testing, and clinical/neuropsychological assessments over about 26 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 15, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Study completion
May 30, 2028 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
May 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Arialys Australia Pty Ltd
Collaborators
  • Arialys Therapeutics
  • Seoul National University Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
legally authorized representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
eligibility criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
at Screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
stable dose
A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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