Paroxysmal Nocturnal Hemoglobinuria, PNHPhase 1NCT07760467
To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
A Phase 1 study testing Part1: TUL321 and Part2: TUL321 in people with Paroxysmal Nocturnal Hemoglobinuria, PNH, run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria, PNH
- What is being tested?
- Part1: TUL321 and Part2: TUL321
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2026to 8 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Third Xiangya Hospital of Central South University
Changsha, Hunan
Guoping Yang, +86-13974817168, ygp9880@163.com
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, PNH
- Being tested
- Part1: TUL321, Part1: Placebo, Part2: TUL321, Part2: Placebo
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part1: TUL321Drug
Also called TUL321
orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg
Part1: PlaceboDrug
Also called Placebo
Oral placebo capsules matching TUL321 capsules
Part2: TUL321Drug
Also called TUL321
orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Part2: PlaceboDrug
Also called Placebo
Oral placebo capsules matching TUL321 capsules
| Study group | Role | What they receive |
|---|---|---|
| TUL321 | Experimental | Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect. Receives: Drug: Part1: TUL321; Drug: Part2: TUL321 |
| Placebo | Placebo comparator | Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control. Receives: Drug: Part1: Placebo; Drug: Part2: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Measured: up to 17 days
Secondary outcomes (6)
Peak plasma concentration (Cmax)
Measured: Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax)
Measured: Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in urine
Measured: Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in feces
Measured: Pre-dose to 144 hours post-dose
Alternative pathway (AP) activity
Measured: Pre-dose to 144 hours post-dose
Bb concentration
Measured: Pre-dose to 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start26 Aug 2026
- Primary completion8 May 2027 (estimated)
- Study completion8 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Nocturnal Hemoglobinuria, PNHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760467
- Sponsor's protocol ID
- TUL-TUL321（I-2）202605
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07760467
- Acronym / sponsor ID
- TUL-TUL321（I-2）202605
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, PNH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 8 May 2027 (estimated)
- Study completion
- 8 May 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUL321 | Experimental | Drug: Part1: TUL321, Drug: Part2: TUL321Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect. |
| Placebo | Placebo comparator | Drug: Part1: Placebo, Drug: Part2: PlaceboHealthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part1: TUL321Also: TUL321orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg | Drug | TUL321 |
| Part1: PlaceboAlso: PlaceboOral placebo capsules matching TUL321 capsules | Drug | Placebo |
| Part2: TUL321Also: TUL321orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID | Drug | TUL321 |
| Part2: PlaceboAlso: PlaceboOral placebo capsules matching TUL321 capsules | Drug | Placebo |
Primary outcome
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Time frame: up to 17 days
6 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax)
Time frame: Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in urine
Time frame: Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in feces
Time frame: Pre-dose to 144 hours post-dose
Alternative pathway (AP) activity
Time frame: Pre-dose to 144 hours post-dose
Bb concentration
Time frame: Pre-dose to 144 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoping Yang principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part1: TUL321 and Part2: TUL321 in people with Paroxysmal Nocturnal Hemoglobinuria, PNH, run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoping Yang (+86-13974817168, ygp9880@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests (time frame: up to 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.