Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441227
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-28
Brief Title:
Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects
Sponsor:
Shandong Suncadia Medicine Co Ltd
Organization:
Shandong Suncadia Medicine Co Ltd
Study Overview
Official Title:
Phase I Clinical Study on the Safety Tolerability and Pharmacokinetics Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This is a randomized double-blind placebo-controlled phase I clinical study The primary objective is to evaluate the safety tolerability PK and PD of single- and multiple-dose HRS-5346 in healthy subjects and to evaluate the food effects on PK of HRS-5346
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