Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 6:26 PM
Study NCT ID:
NCT05369767
Status:
UNKNOWN
Last Update Posted:
2022-11-30
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection 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?: