NCT06359600

A Study of HS-10501 Tablets in Healthy Subjects

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HS-10501 tablet	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2024-03-14
• Primary completion: 2025-01-31
• Completion: 2025-06-30
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China