NCT07760467 To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
| NCT ID | NCT07760467 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhuhai United Laboratories Co., Ltd. |
| Condition | Paroxysmal Nocturnal Hemoglobinuria, PNH |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2026-08-26 |
| Primary Completion | 2027-05-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 94 participants in total. It began in 2026-08-26 with a primary completion date of 2027-05-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Age 18-45 years (inclusive) at informed consent, male or female. 3. Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive). 4. 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. 5. 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: 1. Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies. 2. Past history of tuberculosis infection or active tuberculosis at screening. 3. Known or suspected history of immunodeficiency, inherited or acquired complement deficiency. 4. Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening. 5. History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b. 6. Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening. 7. 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. 8. eGFR \<90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening. 9. Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening. 10. Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study. 11. 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). 12. Average daily cigarette consumption \>5 cigarettes within 3 months before screening. 13. History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test. 14. Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection. 15. Required or plan to perform heavy physical labor or strenuous exercise during study participation. 16. Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening. 17. Acute illness or concomitant medication occurs from screening to pre-first-dose. 18. Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study). 19. Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope. 20. Investigator judges that the subject is unsuitable for this study for any other reason.
Contact & Investigator
Guoping Yang
PRINCIPAL INVESTIGATOR
The Third Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT07760467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Paroxysmal Nocturnal Hemoglobinuria, PNH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07760467 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07760467 currently recruiting?
Yes, NCT07760467 is actively recruiting participants. Contact the research team at ygp9880@163.com for enrollment information.
Where is the NCT07760467 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07760467 clinical trial?
NCT07760467 is sponsored by Zhuhai United Laboratories Co., Ltd.. The principal investigator is Guoping Yang at The Third Xiangya Hospital of Central South University. The trial plans to enroll 94 participants.