NCT07342257

SYN023 With Rabies Vaccine in Healthy Pediatric Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Synermore Biologics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rabies Post-exposure Prophylaxis

Interventions

Type	Name	Description
BIOLOGICAL	SYN023	SYN023 should be administered intramuscularly at sites distant from the vaccine injection site, either at the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.
BIOLOGICAL	Rabies Vaccine	Dosage and administration of Rabies vaccine for human use: 0.5 mL, intramuscular injection in the deltoid muscle; Injection time: Days 0, 3, 7, 14, and 28 (Essen 5-dose regimen).
BIOLOGICAL	HRIG	HRIG should be administered intramuscularly at sites distant from the vaccine injection site, either in the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-05-09
• Completion: 2025-07-23
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: China