drugset / Trial / NCT05846568

Study to Evaluate GR1801's Efficacy and Safety

NCT05846568

Phase 3 Completed 1200 enrolled Genrix (Shanghai) Biopharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this clinical trial is to compare the efficacy and safety of GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure. Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.

Timeline

Start
2022-10-21
Primary completion
2023-09-06
Completion
2024-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject GR1801 Monoclonal antibody 0.05 mg/kg Other
Comparator Human Rabies Immunoglobulin Protein / enzyme biologic 20 iu/kg Other
Background Rabies vaccine Vaccine 2.5 iu Intramuscular

Indications