Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04495569
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-05-10
Brief Title:
A Bridging Study of the SYN023 on Healthy Adult Subjects
Sponsor:
Synermore Biologics Suzhou Co Ltd
Organization:
Synermore Biologics Suzhou Co Ltd
Study Overview
Official Title:
A Phase 1 Single Center Parallel Open Label Bridging Study to Evaluate on the Safety Pharmacokinetic Pharmacodynamics and Anti-drug Antibodies ADA of a Single Intramuscular Doses of SYN023 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2020-06
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 Phase I bridging clinical trial is to evaluate on the safety pharmacokinetics PK pharmacodynamics PD and ADA of a single intramuscular injection of recombinant anti-rabies human monoclonal antibody injection SYN023 alone or combined with rabies vaccine in healthy subjects The study primary purpose was to compare the pharmacokinetics PK between US and China subjects therefore to lay a foundation for the follow-up clinical trials The secondary purpose was to evaluate the PK PD Safety and ADA of SYN023 in Chinese Healthy subjects and compare with that of US subjects
Detailed Description:
In this bridging study the Pharmacodynamic Pharmacokinetic Safety and ADAAnti-Drug Antibodies were evaluated and compared between US and China subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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