NCT05429723

First-in-Human Study to Investigate the Safety and Tolerability and Pharmacokinetics of HS-10383

A Randomized, Double-Blind, Placebo Controlled, Phase I Study to Assess, Safety, Tolerability, Pharmacokinetics of HS-10383 Administered Orally in China Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 using a randomized, double blind, placebo controlled, single center study design. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be one single dose of study drug/placebo received on only one day. The total study duration for each participant will be usually no more than 10 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Detailed description

HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 administered orally to healthy volunteers.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	HS-10383	HS-10383 administered as one 50 mg, 150 mg, 450 mg and 900 mg tablet once daily, depending upon randomization.
DRUG	HS-10383 Placebo	Placebo for HS-10383

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2022-06-23
• Last updated: 2022-07-01

Locations

1 site across 1 country: China