Study to Evaluate GR1801's Efficacy and Safety

PHASE3CompletedINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

October 21, 2022

Primary Completion Date

September 6, 2023

Study Completion Date

September 6, 2024

Conditions
Rabies Post-exposure Prophylaxis
Interventions
BIOLOGICAL

GR1801

The injection solution GR1801 does not contain preservatives. The excipients include histidine/histidine hydrochloride (20mM), trehalose (90 mg/mL), disodium EDTA (0.372mg/mL) and polysorbate 80 (0.5 mg/mL). The pH value is 5.8 and each bottle contains 2mg of GR1801 protein. The packaging material is a borosilicate glass tube injection bottle (2mL) with a halogenated butyl rubber stopper for injection and an aluminum-plastic composite cap for antibiotic bottles.

BIOLOGICAL

Human Rabies Immunoglobulin(HRIG)

The HRIG is a Chinese licensed Human Rabies Immunoglobulin produced by BOYA-BIO, which are derived from human plasma, and then purified and filled in the injectable vial form.

BIOLOGICAL

Rabies Vaccine

The Chinese licensed freeze-dried rabies vaccine produced by CHENGDA PHARMACEUTICALS for human use (Vero Cells) which is indicated for the rabies Post-exposure Prophylaxis (PEP) .

Trial Locations (1)

650000

Center for Disease Control and Prevention (CDC), Kunming

All Listed Sponsors
lead

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY