NCT03961555

Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies

A Phase 2b Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Different Rabies Exposure Risks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Synermore Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll sequentially two different risk substrata of WHO Category 3 rabies exposure which are Low Risk Group (LRG) and Normal Risk Group (NRG). The enrollment will be stepwise while subject's data will be reviewed by data and safety monitoring board (DSMB) to confirm the safety and permit for next enrollment. Besides, rabies vaccine would be administered within 75 minutes after Study Drug in each group. This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in the United States.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	SYN023	it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
BIOLOGICAL	HRIG (HyperRab)	it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
BIOLOGICAL	Rabies vaccine	it should be administered in deltoid muscle

Timeline

• Start date: 2019-09-03
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2019-05-23
• Last updated: 2026-01-16
• Results posted: 2026-01-16

Locations

14 sites across 2 countries: United States, Philippines

Regulatory

• FDA-regulated drug study