NCT06383897

Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation clinical trial. The primary objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple oral doses of HS-10398 in Chinese healthy participants. The secondary objective is to assess the impact of food on the pharmacokinetics of single oral doses of HS-10398 in Chinese healthy participants, as well as to evaluate the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-31
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

1 site across 1 country: China