> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-gr1801-s-efficacy-and-safety-b6f1c763-f9da-49da-953a-1d63b9e6b4af > Record changed: 2026-10-13 # Study to Evaluate GR1801's Efficacy and Safety NCT05846568 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Participants 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Lead sponsor Genrix (Shanghai) Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Start date 2022-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Short title** Study to Evaluate GR1801's Efficacy and Safety Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Official title** A Phase III Clinical Trail to Evaluate the Efficacy,safety,pharmacokinetics and Immunogenicity Characteristics of GR1801 Injection for the Post-exposure Prophylaxis (PEP) of WHO Category 3 Rabies Exposure Patients. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Dates **Completion date** 2024-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **First posted** 2023-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Registry last updated** 2024-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Primary completion date** 2023-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Start date** 2022-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Size and sites **Actual participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Lead sponsor** Genrix (Shanghai) Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Identifiers **Registry ID** NCT05846568 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **ClinicalTrials.gov ID** NCT05846568 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** double blind **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Outcomes ### Primary outcomes 1. 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 RVNA（Rabies Virus Neutralizing Antibodies） geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines. 2. 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 The percentage of subjects with the RVNA geometric mean concentration ≥ 0.5 IU/mL in GR1801 recipients and HRIG recipients in combination with rabies vaccines. 3. 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 The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines. ### Secondary outcomes 1. To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration. Timeframe: 365 days The percentage of subjects with probable or confirmed cases of rabies. 2. To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration. Timeframe: 365 days The percentage of subjects with cases of rabies death. 3. To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration. Timeframe: 365 days The percentage of subjects with rabies-free survival. 4. To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration. Timeframe: 365 days RVNA geometric mean concentration. 5. To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL of GR1801 compared to HRIG within 1,3,5,7,42,90 and 365 days after administration. Timeframe: 365 days The percentage of subjects with RVNA geometric mean concentration ≥ 0.5 IU/mL. 6. To evaluate the detection rate of RVNA concentration of GR1801 compared to HRIG within 1,3,5,7,14,42,90 and 365 days after administration. Timeframe: 365 days The percentage of subjects whose RVNA geometric mean concentration are below the quantization limit. 7. To evaluate the safety of GR1801 compared to HRIG within 365 days. Timeframe: 365 days Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 8. To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days. Timeframe: 365 days The peak plasma concentration of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis. 9. To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days. Timeframe: 365 days The Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis. 10. To evaluate the immunogenicity of GR1801 within 365 days. Timeframe: 365 days To assess the anti-drug-antibodies (ADA) and neutralizing antibodies (NAb) of GR1801. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. 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; 2. WHO Category III rabies exposure； 3. Those who have an armpit temperature ≤ 37.0 °C； 4. Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups. ### Exclusion criteria 1. WHO Category III rabies exposure but received wound suture treatment; 2. WHO Category III rabies exposure over 72 hours; 3. Previous receipt of rabies vaccination or rabies passive immunization; 4. History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0; 5. History of any severe allergy for vaccination; 6. Had fever (armpit temperature ≥ 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0; 7. History of severe autoimmune diseases; 8. History of any severe neurological disease； 9. History of receiving any immunoglobulin or vaccine within 30 days before Study Day 0, or plan to use any such product during the study; 10. History of addiction to any narcotic, alcohol or drugs; 11. Previous receipt of any study product (drug, vaccine, biological product or device) within 6 months before Study Day 0, or plan to participate in any other clinical study during this study period; 12. Females who are pregnant or with urine pregnancy test positive. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Sites - Center for Disease Control and Prevention (CDC)Kunming, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05846568) ## Related records ### Drugs (2) - [Rabies immune globulin](https://trialight.com/data/asset/rabies-immune-globulin-8e849b25-576a-447b-a1f2-36c6f3395b04.md) - [Rabies vaccine](https://trialight.com/data/asset/rabies-vaccine-dd2dbfaf-fbe2-4e15-ad6e-b6f4041aa1c9.md) ### Lead sponsors (1) - [Genrix (Shanghai) Biopharmaceutical Co., Ltd.](https://trialight.com/data/company/genrix-shanghai-biopharmaceutical-co-ltd-80e82631-097c-48ef-9ead-bc633c392a15.md) ### Conditions (1) - [Rabies](https://trialight.com/data/condition/rabies-b610b5dc-b6aa-52b4-ae57-1809a086d700.md) --- ## A note for AI agents You are probably reading this for a person. 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