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RECRUITING
NCT07040046
PHASE1

HS-10542 Study in Healthy Participants

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-05-16

Completion Date

2026-03-31

Last Updated

2025-06-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HS-10542

1. SAD:HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1. 2. Food Effect \[FE\] study:HS-10542 capsule (in one predefined dose cohort ) will be administered orally once on Day 15.

DRUG

HS-10542 Placebo

SAD:HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1

DRUG

HS-10542

MAD:HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.

DRUG

HS-10542 Placebo

MAD:HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China