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Silevimig (GR1801) for Rabies Post-exposure Prophylaxis
NCT05846568Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2022
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- Zhixiang Jintai
- Modality
- Bispecific Antibodies
- Drugs
- silevimig
- Conditions
- rabies
01
Overview
Phase 3, randomised, double-blind trial of silevimig in rabies (2 arms), sponsored by Zhixiang Jintai. Primary endpoints: Geometric Mean Rabies Virus Neutralizing Antibody Concentration at 7 days, Percentage of Subjects with RVNA Concentration >= 0.5 IU/mL at 14 days and 1 more. Started Oct 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Silevimig + Rabies Vaccine
Single dose of Silevimig (0.05 mg/kg) via wound infiltration/IM on Day 0 + Rabies Vaccine (5 doses).
HRIG + Rabies Vaccine
Single dose of HRIG (20 IU/kg) via wound infiltration/IM on Day 0 + Rabies Vaccine (5 doses).
03
Endpoints
Primary
Geometric Mean Rabies Virus Neutralizing Antibody Concentration
Percentage of Subjects with RVNA Concentration >= 0.5 IU/mL
Rabies Post-exposure Protection Rate
Secondary
Rabies Post-exposure Morbidity
Rabies Post-exposure Mortality
Rabies Post-exposure Survival Rate
Geometric Mean RVNA Concentration
Percentage of Subjects with RVNA Concentration >= 0.5 IU/mL
Adverse Events and Serious Adverse Events
Peak Plasma Concentration
Area Under the Plasma Concentration versus Time Curve
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