Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
Completed · Phase 2
Conditions studied: Rabies
In brief
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.
Key facts
- Study ID
- NCT03961555
- Run by
- Synermore Biologics Co., Ltd.
- People needed
- 448
- Starts
- 2019-09-03
- Expected to finish
- 2021-12-23
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects must have had none of the following at the time of subject ID assignment:
- Clinical evidence of rabies infection
- Category 3 exposure > 54 hours before Study Drug receipt
- History or serological evidence of previous rabies vaccination
- Previous receipt of equine or human rabies globulin
- History of hypersensitivity reaction to equine or human immunoglobulin.
- Received immunoglobulin or blood products within 42 days before Study Day 1
- Received any investigational drug therapy or investigational vaccine within 60 days before Study Day 1
- Planned participation in any other investigational study during the study period.
- Receiving systemic immunosuppressant medication such as systemic corticosteroids but not limited to systemic corticosteroids
- History or laboratory evidence of any past, present, or possible immunodeficiency state including but not limited to any laboratory indication of HIV infection
- Previous medical history that may compromise the safety of the subject in the study according to the opinion of the principal investigator
- History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or activity of SYN023
- Pregnancy (results of the urine pregnancy test MUST be known before enrollment)
Where it is running
- University of Florida — Gainesville, Florida, United States
- University of Iowa — Iowa City, Iowa, United States
- Clinical Research Solutions PC -Milan — Milan, Tennessee, United States
- University of Virginia — Charlottesville, Virginia, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Baguio General Hospital and Medical Center — Baguio City, Benguet, Philippines
- De La Salle Health Sciences Institute Independent Ethics Committee — Cavite City, Calabarzon, Philippines
- Southern Philippines Medical Center — Davao City, Davao (Region XI), Philippines
- Manila Doctors Hospital Institutional Review Board — Manila, National Capital Region, Philippines
- Asian Hospital and Medical Center — Muntinlupa, National Capital Region, Philippines
- Center of Excellence in Drug Research, Evaluation and Studies, Inc. — Muntinlupa, National Capital Region, Philippines
- Research Institute For Tropical Medicine — Muntinlupa, National Capital Region, Philippines
- Far Eastern University Hospital Nicanor Reyes Medical Foundation — Quezon City, National Capital Region, Philippines
- Mary Johnston Hospital — Manila, Philippines
Full record on ClinicalTrials.gov
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