RecruitingPhase 1NCT07760467

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

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

Sponsor

Zhuhai United Laboratories Co., Ltd.

Enrollment

94 participants

Start Date

Aug 26, 2026

Study Type

INTERVENTIONAL

Conditions

Paroxysmal Nocturnal Hemoglobinuria, PNH

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

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Part1: Placebo, a drug called Part1: TUL321, and others for people with paroxysmal nocturnal hemoglobinuria, pnh. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPart1: TUL321

orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg

DRUGPart1: Placebo

Oral placebo capsules matching TUL321 capsules

DRUGPart2: TUL321

orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID

DRUGPart2: Placebo

Oral placebo capsules matching TUL321 capsules

Locations(1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07760467

Related Trials

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

NCT035206471 location

Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients

NCT0693496713 locations

A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria With Persistent Anemia on a C5 Inhibitor

NCT071874018 locations

A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT0490193612 locations

REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria

NCT0722923512 locations