Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359600
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-21
Brief Title:
A Study of HS-10501 Tablets in Healthy Subjects
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Dose Escalation Phase I Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of HS-10501 Tablets After Single and Multiple Oral Doses in Healthy Subjects
Status:
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:
The purpose of this study is to evaluate the safety tolerability Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects This is the first clinical study of HS-10501 tables This study has 2 parts Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days Also this part will also further explore the food effect Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks
Detailed Description:
None
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