Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554043
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2020-08-31
Brief Title:
The PKPD Study of SHR7280 Tablets in Healthy Subjects
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Dose-escalation Placebo-controlled Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of SHR7280 Tablets in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
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 primary objective of this study is to assess the safety tolerability pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects
Detailed Description:
GNRH antagonists can be used to treat sex hormone-dependent diseases and SHR7280 is an oral GNRH antagonist The purpose of this study is to observe the safety tolerability pharmacokinetics and pharmacodynamics of multiple oral doses of SHR7280 in healthy subjects
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