SYN023 With Rabies Vaccine in Healthy Pediatric Subjects

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.

NCT Number	NCT07342257
Lead Sponsor	Synermore Biologics (Suzhou) Co., Ltd. Collaborators: Guizhou Center for Disease Control and Prevention
Conditions	Rabies Post-exposure Prophylaxis
Enrollment	108 participants
Start Date	2024-11-30
Primary Completion	2025-05-09 (estimated)
Study Completion	2025-07-23 (estimated)
Updated on ClinicalTrials.gov	2026-01-15