Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-01 @ 8:31 PM
Study NCT ID:
NCT07078695
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1139 in Healthy Volunteers
Sponsor:
Atridia Pty Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2025-07
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 assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: