Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:31 AM
Study NCT ID:
NCT07342257
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SYN023 With Rabies Vaccine in Healthy Pediatric Subjects
Sponsor:
Synermore Biologics (Suzhou) Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Active-Controlled, Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Zamerovimab and Mazorelvimab Injection (SYN023) in Combination With Rabies Vaccine in Healthy Subjects Under 18 Years of Age
Status:
COMPLETED
Status Verified Date:
2025-12
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 a randomized, double-blind, active-controlled design. The goal is to evaluate the safety, pharmacokinetics and pharmacodynamic of SYN023 in combination with rabies vaccine in healthy participants under 18 years of age.
Participants will:
1. Be randomly assigned to receive one of two doses of SYN023 or a dose of HRIG by intramuscular injection on Day 0, along with the first dose of the rabies vaccine.
2. Receive additional doses of the rabies vaccine on Days 3, 7, 14, and 28.
3. Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
4. Provide several blood samples for pharmacokinetics and pharmacodynamic testing.
Participants will:
1. Be randomly assigned to receive one of two doses of SYN023 or a dose of HRIG by intramuscular injection on Day 0, along with the first dose of the rabies vaccine.
2. Receive additional doses of the rabies vaccine on Days 3, 7, 14, and 28.
3. Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
4. Provide several blood samples for pharmacokinetics and pharmacodynamic testing.
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?:
False
Is an FDA AA801 Violation?: