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

NCT03961555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2026-01-16

Study results available
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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

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

Sponsors & Collaborators

  • Synermore Biologics USA Limited

    collaborator UNKNOWN

  • Synermore Biologics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2021-12-23
Completion
2021-12-23
FDA Drug
Yes

Countries

  • United States
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961555 on ClinicalTrials.gov