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RECRUITING
NCT06359600
PHASE1

A Study of HS-10501 Tablets in Healthy Subjects

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10501 Tablets After Single and Multiple Oral Doses in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-03-14

Completion Date

2025-06-30

Last Updated

2024-04-11

Healthy Volunteers

Yes

Interventions

DRUG

HS-10501 tablet

Administered orally

DRUG

Placebo

Administered orally

Locations (1)

The second hospital of Anhui University

Hefei, Anhui, China