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RECRUITING
NCT07760467
PHASE1

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

Sponsor: Zhuhai United Laboratories Co., Ltd.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2026-08-26

Completion Date

2027-05-08

Last Updated

2026-09-01

Healthy Volunteers

Yes

Interventions

DRUG

Part1: TUL321

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

DRUG

Part1: Placebo

Oral placebo capsules matching TUL321 capsules

DRUG

Part2: TUL321

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

DRUG

Part2: Placebo

Oral placebo capsules matching TUL321 capsules

Locations (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, China