Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383897
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-06-20
Brief Title:
Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None