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NOT YET RECRUITING
NCT07841522
PHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW243040 in Healthy Participants

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HW243040 in healthy participants. The study consists of two parts: Part A (Single Ascending Dose, SAD) and food effect study, and Part B (Multiple Ascending Dose, MAD). A total of approximately 98 healthy participants will be enrolled.

Official title: A Phase I, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW243040 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-09-30

Completion Date

2027-07-31

Last Updated

2026-09-25

Healthy Volunteers

Yes

Interventions

DRUG

HW243040

HW243040 tablets, 50mg and 200mg规格, administered orally. Doses range from 50mg to 1200mg as a single dose in Part A, or 150mg to 600mg twice daily for 5 days in Part B. Administered with 240mL water under fasting or fed (high-fat, high-calorie meal) conditions as specified per arm.

DRUG

HW243040 Matching Placebo

HW243040 matching placebo tablets, 50mg and 200mg规格, identical in appearance to HW243040 active tablets. Administered orally with 240mL water under the same conditions as the corresponding active dose arm.