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Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
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
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