NCT04880512

The Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects

A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses and multiple ascending doses of SYHX1901 tablets in Chinese healthy subjects

Detailed description

This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses (part 1) and multiple ascending doses (part 2) of SYHX1901 tablets in Chinese healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SYHX 1901 tablets	SYHX 1901, oral tablets, in fasted state
DRUG	Placebo	Matching placebo, oral tablets, in fasted state

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-08-20
• Completion: 2022-12-20
• First posted: 2021-05-10
• Last updated: 2021-09-30

Locations

1 site across 1 country: China