ClinicalTrials.gov record NCT07760467

To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics

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 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 45 years old
SexAll
LocationChina
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 I interventional study evaluates oral TUL321 capsules to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the effect of a high‑fat meal. The registry lists Paroxysmal Nocturnal Hemoglobinuria (PNH) as the condition, while the study description states it enrolls healthy participants in single‑ and multiple‑dose parts and a food‑effect sub‑study. Participants are randomized to receive TUL321 or matching placebo in single ascending‑dose and multiple‑dose cohorts.

What it is studying. The study is testing how oral TUL321 behaves in the body and whether it is safe and tolerated. It looks at safety and tolerability after single and repeated doses; measures how the drug is absorbed, distributed, metabolized and eliminated (pharmacokinetics); examines biological effects (pharmacodynamics) including alternative pathway activity and Bb concentration; studies how a high‑fat meal changes drug levels; assesses in vivo biotransformation and mass balance; and evaluates effects on the heart's electrical interval (QT/QTc).

What the researchers hope to learn. Scientific goals: evaluate safety and tolerability of single and multiple oral doses of TUL321; characterize PK profiles after single and multiple dosing; evaluate the effect of a high‑fat meal on PK; preliminarily assess in vivo biotransformation and mass balance; characterize PD profiles; and evaluate effects on the QT/QTc interval.

What this study is about

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

Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK

Interventions being studied

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

Drug
  • Part1: TUL321
  • Part1: Placebo
  • Part2: TUL321
  • Part2: Placebo

Eligibility

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

Inclusion criteria

  • Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
  • Age 18-45 years (inclusive) at informed consent, male or female.
  • Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
  • Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
  • For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.

Exclusion criteria

  • Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
  • Past history of tuberculosis infection or active tuberculosis at screening.
  • Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
  • Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
  • History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
  • Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
  • QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
  • eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
  • Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
  • Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
  • Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
  • Average daily cigarette consumption >5 cigarettes within 3 months before screening.
  • History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
  • Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
  • Required or plan to perform heavy physical labor or strenuous exercise during study participation.
  • Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
  • Acute illness or concomitant medication occurs from screening to pre-first-dose.
  • Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
  • Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
  • Investigator judges that the subject is unsuitable for this study for any other reason.

Study description and what participation involves

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

Detailed description from the registry

Primary Objective: To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants. Secondary Objectives:

  • To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
  • To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
  • To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
  • To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
  • To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.
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 are randomly assigned to take oral TUL321 capsules or matching placebo in single ascending‑dose and multiple‑dose parts; a food‑effect sub-study includes taking a high‑fat meal before a dose. Study visits include screening tests (physical exam, vital signs, laboratory tests, ECG, chest X‑ray and abdominal ultrasound) and, for some multiple‑dose participants, required vaccinations (ACYW135 meningococcal and pneumococcal) at least 14 days before first dose. After dosing participants give samples to measure drug levels and biotransformation — including blood samples and collections of urine and feces over the hours and days after dose — and have ECGs and other safety checks for adverse events. Pharmacokinetic sample collection is performed up to about 144 hours after dose and safety assessments are followed (primary safety outcomes up to 17 days); the study team will provide the exact visit schedule and procedures.

How the study is structured. Randomized, quadruple‑masked Phase I interventional study with a sequential design. Part 1 uses single ascending oral doses (20, 50, 100, 200, 400 and 600 mg) and Part 2 uses multiple oral dosing (50 mg QD, 100 mg QD, 300 mg QD, 50 mg BID), with matching placebo groups. A food‑effect sub‑study compares PK after a high‑fat meal. Main assessments include adverse events, physical exams, ECGs and lab tests (up to 17 days) and PK/PD measurements up to 144 hours after dosing.

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 listed sites are in China. 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 paroxysmal nocturnal hemoglobinuria

Clinical trials44 trials listed for paroxysmal nocturnal hemoglobinuriaEvery trial the registry lists for paroxysmal nocturnal hemoglobinuria, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in paroxysmal nocturnal hemoglobinuria researchLatest monthly update: September 2026. Includes: Treatment access. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 26, 2026
Primary completion
May 8, 2027 (estimated)
Study completion
May 8, 2027 (estimated)
Target enrollment
94 participants (estimated)
Last updated on registry
Sep 1, 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
Zhuhai United Laboratories Co., Ltd.

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

PK
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.
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.
investigational product
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.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
concomitant medication
Other medicines a participant takes during the study. Some must be reported; some are restricted.
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.
Primary Objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
pharmacodynamic
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.

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 website; 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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