Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863442
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-03-17
Brief Title:
Comparative PK Safety Tolerability Immunogenicity and PD Profile Study of TUR03 and Soliris in Healthy Participants
Sponsor:
Turgut Ardika PTY LTD
Organization:
Turgut Ardika PTY LTD
Study Overview
Official Title:
A First-in-human Randomized Double-blind Parallel-group Study to Evaluate the PK Safety Tolerability Immunogenicity and PD Profile of a Single Intravenous Dose of TUR03 Compared With Soliris in Healthy Adult Male Participants
Status:
RECRUITING
Status Verified Date:
2023-11
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 study is designed as a randomized double-blind parallel-group study to evaluate the PK safety tolerability immunogenicity and PD of TUR03 compared to Soliris when administered as a single IV infusion in healthy adult male participants
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