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

Cough Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05429723
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Wei Zhao, Doctor
Phone 15131190710
Email zhao4wei2@hotmail.com
Status Recruiting
Phase Phase 1
Start date March 1, 2022
Completion date June 30, 2022
View Details
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