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NOT YET RECRUITING
NCT06383897
PHASE1

Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and the Impact of Food on Pharmacokinetics of HS-10398 in Healthy Participants, and a Clinical Trial to Assess the Pharmacokinetic Characteristics of HS-10398 in Participants With Kidney Dysfunction

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2024-05-31

Completion Date

2025-01-31

Last Updated

2024-04-25

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HS-10398

SAD:HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD:HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF:HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction

DRUG

HS-10398 Placebo

SAD:HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD:HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, China