ClinicalTrials.gov record NCT07869654

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults

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

A Phase 1 Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
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 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 60 years old
SexAll
LocationUnited States
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 1, randomized study gives single and multiple ascending oral doses of ATI-105 or matching placebo to healthy adults (ages 18–60). Some participants receive a second dose to evaluate whether taking ATI-105 with or without food changes how the drug is processed. Participation includes short inpatient clinic stays for dosing and monitoring, plus follow-up visits with vital checks and blood draws. A safety committee reviews data before advancing to higher dose groups.

What it is studying. Whether single doses and 14-day multiple ascending doses of oral ATI-105 are safe and tolerated in healthy adults, and the drug's pharmacokinetics (how the body absorbs, distributes, and clears ATI-105), including any effect of food on those measures.

What the researchers hope to learn. Collect human safety and tolerability data and detailed pharmacokinetic measurements (for example Cmax, Tmax, AUC, clearance, and related parameters) across single and multiple dosing. Evaluate whether food affects ATI-105 exposure. These data will inform dose selection and whether ATI-105 should be studied further for Friedreich's ataxia and related conditions.

What this study is about

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

The goal of this clinical trial is to learn how ATI-105 administered to healthy participants at works in the body at different doses and with or without food. The outcomes of this clinical trial will help to determine if ATI-105 may be able to treat patients with Friedreich's ataxia, a rare and life-threatening nerve-muscle disease that worsens over time. The main questions this study is designed to answer include the following:

  • How do single doses or doses for 14 days work in the body?
  • Are these doses safe and tolerated?
  • Should ATI-105 be taken with or without food?

Some participants will receive a placebo, which is an inactive substance, so the drug can be compared against it. This will help researchers determine if the drug is tolerated by participants, if there are adverse effects, and how the drug acts in the body and if there are any changes. The study will include some participants who will be assigned by chance to receive an inactive substance (placebo) that appears like the active drug product. Qualifying participants who enroll into the first of two study portions will randomly be assigned to one of three dose groups to receive a single dose of ATI-105 or a placebo. Some of the participants will receive a second dose to inform whether ATI-105 should be taken with or without food. Qualifying participants who enroll into the second study portion will receive ATI-105 or placebo for 14 days and will be randomly assigned to one of three dosing groups. For both portions, a safety committee will review the safety and tolerability data for each dosing group to determine if the dose can be increased for the next dosing group. Participants will be required to stay over night in the clinic for a few days and come back for visits after for procedures that include a check of their vitals and blood draws.

Interventions being studied

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

Drug
  • ATI-105
  • Placebo

Eligibility

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

Inclusion criteria

  • Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
  • Males and females 18-60 years of age, inclusive.
  • Medically healthy by history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations (hematology, serum chemistry, coagulation, urinalysis).
  • Body mass index (BMI) of 18.0-35.0 kg/m2, inclusive.
  • Able to swallow capsules.
  • Males and females of childbearing potential must be willing to use an effective method of contraception (hormonal or double barrier method of birth control; abstinence) from the time consent is signed until 37 days after treatment discontinuation (i.e., 30 days + 5 half-lives of ATI-105).

Exclusion criteria

  • Any clinically significant disease or condition which, in the opinion of the Investigator, could affect participant safety or confound study results.
  • Pregnant or lactating subjects. 3. Use of prescription/over-the-counter (OTC) medications, herbal products, or supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing, or current use of any investigational medication. Thyroid medications with a stable dose for 1 year are acceptable.
  • Use of glucagon-like peptide-1 (GLP-1) agonists. 5. Positive test for drugs of abuse or alcohol. 6. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), per institutional laboratory test.
  • Positive test for influenza or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive test for SARS-CoV-2 within 30 days prior to screening, or current long COVID.
  • Laboratory abnormalities including but not limited to:
  • Hemoglobin <10 g/dL
  • White blood cells <3.0 × 103/μL
  • Neutrophils ≤1500/μL
  • Platelet count <150 × 109/L
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN)
  • Total bilirubin >1.2 mg/dL
  • Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

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 will be randomly assigned to take oral capsules of ATI-105 or a matching placebo as a single dose or daily for 14 days; some people will receive a second dose to test taking the drug with or without food. Participants will need to stay overnight in the clinic for a few days and return for follow-up visits. Study procedures explicitly include checks of vital signs and blood draws, and the study will collect reports of any side effects. A safety committee will review safety and tolerability data between dose groups to decide on dose increases.

How the study is structured. Phase 1, randomized, parallel-group study with ATI-105 and matching placebo arms. The trial uses single-ascending-dose and multiple-ascending-dose parts, is quadruple-masked, and includes a safety review process to decide dose escalation. Some participants will receive an additional dosing condition to study the effect of food on drug levels.

Questions you could ask

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

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. 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 Friedreich ataxia

Clinical trials26 trials listed for Friedreich ataxiaEvery trial the registry lists for Friedreich ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Friedreich ataxia researchLatest monthly update: September 2026. Includes: Heart change stages. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 26, 2026 (estimated)
Primary completion
May 27, 2027 (estimated)
Study completion
Jun 27, 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Oct 9, 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
Adjuvia Therapeutics, Inc.
Collaborators
  • Quotient Sciences

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)

  • Quotient Sciences

    Miami, Florida, 33126 · United States

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
randomly assigned
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
written 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.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
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.
investigational
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.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
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.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

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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