NCT05953506

Phase 1a Study in Healthy Participants

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.

Detailed description

This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HS-10506	HS-10506 will be administered orally once on Day 1.
DRUG	HS-10506 Placebo	Matching placebo will be administered orally once on Day 1.

Timeline

• Start date: 2023-07-17
• Primary completion: 2023-12-24
• Completion: 2023-12-24
• First posted: 2023-07-20
• Last updated: 2023-07-20