A Phase 2 interventional study of Recombinant Human Rabies Virus Monoclonal Antibody Injection and Human Rabies Immunoglobulin (HRIG) in Rabies (Healthy Volunteers), sponsored by Lanzhou Institute of Biological Products Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Lanzhou Institute of Biological Products Co., Ltd (part of Sinopharm) · Phase 2, Interventional, and Treatment
A Phase II, Single-Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody Injection in Healthy Subjects
Primary Objective of the study:
（1）To evaluate the safety, tolerability, and Rabies Virus Neutralizing Activity (RVNA) of different doses of a recombinant human anti-rabies virus monoclonal antibody injection (referred to as the anti-rabies mAb), administered alone or in combination with a human rabies vaccine, compared to human rabies immune globulin, in healthy adult participants aged 18-60.
Secondary Objective of the study:
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's planned enrollment of 200 is close to the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Lanzhou Institute of Biological Products Co., Ltd is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
First submitted after Lanzhou Institute of Biological Products Co., Ltd became part of Sinopharm.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection
60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection
60 trial participants were enrolled and randomly assigned at a 1:1:1 ratio to the 40 IU/kg monoclonal antibody group (20 participants), the HRIG control group (20 participants), and the 80 IU/kg monoclonal antibody group (20 participants).
Drug: Human Rabies Immunoglobulin (HRIG)
A total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection · Biological: Rabies Vaccine
A total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection · Biological: Rabies Vaccine
A total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Drug: Human Rabies Immunoglobulin (HRIG) · Biological: Rabies Vaccine
A total of 140 trial participants were enrolled and randomly assigned in a 2:2:2:1 ratio to the following groups: 40 IU/kg monoclonal antibody plus vaccine group (40 participants) HRIG plus vaccine group (40 participants) 80 IU/kg monoclonal antibody plus vaccine group (40 participants) Placebo plus vaccine group (20 participants).
Drug: Placebo · Biological: Rabies Vaccine
On Day 0, administer via intramuscular injection into the lateral thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to co-administer at the same injection site.
On Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
On Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
On Days 0, 3, 7, 14, and 28, administer via intramuscular injection into the deltoid muscle of the upper arm. Injection into the gluteal region is prohibited. The injection on Day 0 should be administered as soon as possible after the administration of the investigational product.
Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.
Local and systemic adverse events (AEs)
Time frame: At least 30 minutes after administration
Occurrence of any local AEs, systemic AEs, and serious adverse events (SAEs) from the administration of the investigational product on Day 0 until the last visit.
Local AEs, systemic AEs, and serious adverse events (SAEs)
Time frame: 0-105 days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Tympanic temperature（℃）
Time frame: 0-105 Days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Systolic Pressure and Diastolic Pressure (Sitting Position) （mmHg）
Time frame: 0-105 Days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Pulse（bpm）
Time frame: 0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（Heart Rate，bpm）
Time frame: 0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（ Heart Rhythm）
Time frame: 0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（ST Segment，mV）
Time frame: 0-105 Days
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
12-lead electrocardiogram（Abnormal Q Wave，ms）
Time frame: 0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Cardiothoracic Ratio，\>0.5）
Time frame: 0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Pulmonary Nodule Size，mm）
Time frame: 0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Costophrenic Angle，cm）
Time frame: 0-105 Days
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Chest X-ray（Tracheal Position，cm）
Time frame: 0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
White Blood Cell Count（×10⁹/L）
Time frame: 0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Hemoglobin（g/L）
Time frame: 0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Platelet Count（×10⁹/L）
Time frame: 0-105 Days
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Neutrophil Percentage（%）
Time frame: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Protein（g/L）
Time frame: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Glucose（mmol/L）
Time frame: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
White Blood Cells in Urine（/μL）
Time frame: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Urine Erythrocytes （/μL）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Blood Glucose （mmol/L）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Potassium （mmol/L）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Creatinine （µmol/L）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Alanine Aminotransferase（U/L）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Sodium（mmol/L）
Time frame: 0-105 Days
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
estimated Glomerular Filtration Rate（mL/min/1.73m²）
Time frame: 0-105 Days
Changes in routine coagulation test results from baseline at different observation time points following administration of the investigational product/vaccine.
Prothrombin Time（s）
Time frame: 0-105 days
Pharmacodynamic Endpoints
The positive rate (with a positivity threshold of RVNA ≥ 0.5 IU/mL) of serum rabies virus neutralizing antibodies (RVNA) were measured at the following time points: within 1 hour before the administration of the investigational product on Day 0, and at 4 hours, 6 hours, 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine.
Time frame: 0-105 Days
Pharmacodynamic Endpoints
The geometric mean concentration (GMC) of serum rabies virus neutralizing antibodies (RVNA) were measured at the following time points: within 1 hour before the administration of the investigational product on Day 0, and at 4 hours, 6 hours, 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine.
Time frame: 0-105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Cmax.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: AUC0-t.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: AUC0-∞.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Tmax.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: t1/2.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Vd/F.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Kel.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: MRT.
Time frame: 105 Days
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: CL/F.
Time frame: 105 Days
Anti-drug Antibodies (ADA)
The positive rate of serum anti-drug antibodies (ADA) against LZR08/LZR07 were assessed within 1 hour before the administration of the investigational product on Day 0 and at 7 days, 28 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. For trial participants who tested positive for ADA, further evaluation was conducted to determine whether these were neutralizing antibodies against LZR08/LZR07.
Time frame: 105 Days
Anti-drug Antibodies (ADA)
The titer of serum anti-drug antibodies (ADA) against LZR08/LZR07 were assessed within 1 hour before the administration of the investigational product on Day 0 and at 7 days, 28 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. For trial participants who tested positive for ADA, further evaluation was conducted to determine whether these were neutralizing antibodies against LZR08/LZR07.
Time frame: 105 Days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Jul 2026, 5 months later.
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Lanzhou Institute of Biological Products Co., Ltd →