Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802811
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2021-03-10
Brief Title:
A Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability and Pharmacokinetics Pharmacodynamics of Oral SHR2150 in Healthy Subjects With Single Dose of SHR2150 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-03
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 study is a randomized Double-Blind Placebo-Controlled study to evaluate the safety tolerability and pharmacokinetics pharmacodynamics of SHR2150
will consist of 50 healthy subjects 5 groups The purpose of this part is to explore the safety tolerability pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects
will consist of 50 healthy subjects 5 groups The purpose of this part is to explore the safety tolerability pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects
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