Study to Evaluate GR1801's Efficacy and Safety

This is a randomized, double‐blind, Human Rabies Immunoglobulin(HRIG) controlled PhaseIII clinical trial evaluating the efficacy, safety, pharmacokinetic and immunogenicity ofGR1801 injection as a part of post‐exposure prophylaxis (PEP) in patients with WHOCategory 3 rabies exposure who have met all inclusion/exclusion criteria for theirtreatment group.1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolledas planned and randomly assigned to the experimental group and the control group based ona ratio of 3: 1. The random stratification factors include time of exposure (within orbeyond 24 hours), bite location (above or below the neck), and number of bites (1 ormore).All the patients should receive wound infiltration injection of GR1801 or HRIG on StudyDay 0 (wound conditions should be described and recorded both before and post injectionby photos, including diameter, depth, expansion treatment, etc.), and should also receiveintramuscular injection of one dose of the freeze‐dried rabies vaccine for human use(Vero cells) into the deltoid muscle after the infiltration injection. Patients shouldalso be given one dose of the freeze‐dried rabies vaccine for human use (Vero cells) onStudy Days 3, 7, 14, and 28 respectively according to the WHO Essen regime.Rabies virus neutralizing antibodies (RVNA) should be collected 9 times from each subjectprior to administration and on Study Day1, 3, 5, 7, 14, 42, 90, 365 post administrationof Study Drug. RVNA should be assayed through rapid fluorescence focus inhibition test(RFFIT). The occurrence of rabies and survival conditions should be collected throughevery follow‐up visit.Adverse events should be classified in accordance with solicited adverse events andunsolicited adverse events. Solicited adverse events include local adverse events (suchas injection sites pain, induration, swelling, redness, rash and pruritus) and systemicadverse events (such as fever, hypersensitivity, headache, fatigue, nausea, vomiting,arthralgia and myalgia). Unsolicited adverse events are those except solicited adverseevents or solicited adverse events beyond 7 days after the first administration.Solicited adverse events should be collected 7 days after the first administration.Unsolicited adverse events should be collected in 3 months after the first administrationand serious adverse events(SAE) should be collected throughout the trial.