drugset / Trial / NCT05429723

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

NCT05429723 ↗

Phase 1 Unknown 32 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2022-03-01
Primary completion
2022-06-30
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10383 Unknown 50 mg Oral
Subject HS-10383 Unknown 150 mg Oral
Subject HS-10383 Unknown 450 mg Oral
Subject HS-10383 Unknown 900 mg Oral

Indications