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HS-10542 Study in Healthy Participants

NCT07040046 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2025-12-04
Completion
2026-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040046 on ClinicalTrials.gov