CompletedPhase 3

Study to Evaluate GR1801's Efficacy and Safety

China1,200 participantsStarted 2022-10-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Chinese males or females aged 18 years or above on Study Day 0 with legal identification documents and plan to live in the local area during the study;
✓. WHO Category III rabies exposure；
✓. Those who have an armpit temperature ≤ 37.0 °C；
✓. Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.

Exclusion criteria

✕. WHO Category III rabies exposure but received wound suture treatment;
✕. WHO Category III rabies exposure over 72 hours;
✕. Previous receipt of rabies vaccination or rabies passive immunization;
✕. History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0;
✕. History of any severe allergy for vaccination;
✕. Had fever (armpit temperature ≥ 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0;
✕. History of severe autoimmune diseases;
✕. History of any severe neurological disease；

What they're measuring

To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7.

Timeframe: 7 days

To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL on Study Day 14 in GR1801 recipients is non-inferior to the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL for HRIG.

Timeframe: 14 days

To evaluate the rabies post-exposure protection rate for GR1801 recipients is non-inferior to the protection rate for HRIG recipients on Study Day 365.

Timeframe: 365 days

Trial details

NCT IDNCT05846568

SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-06

View on ClinicalTrials.gov More Rabies Post-exposure Prophylaxis trials