Rabies (Healthy Volunteers)Phase 2NCT07445815
A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
A Phase 2 study testing Recombinant Human Rabies Virus Monoclonal Antibody Injection, Human Rabies Immunoglobulin (HRIG) and Rabies Vaccine in people with Rabies (Healthy Volunteers), run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies (Healthy Volunteers)
- What is being tested?
- Recombinant Human Rabies Virus Monoclonal Antibody Injection, Human Rabies Immunoglobulin (HRIG) and Rabies Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 21 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification.
- Participants voluntarily agree to participate in the study and sign an informed consent form.
- Female participants must have no plans for pregnancy or egg donation from 14 days prior to dosing until 6 months after dosing and must voluntarily adopt effective physical contraceptive measures. Male participants must have no plans for pregnancy or sperm donation within 6 months after dosing and must voluntarily adopt effective physical contraceptive measures.
- Female participants must weigh ≥45.0 kg and ≤80.0 kg, and male participants must weigh ≥50.0 kg and ≤80.0 kg. Body mass index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight in kg / height in m²).
- Vital signs (reference ranges: systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-100 beats per minute, all inclusive; body temperature assessed by the investigator according to the research center's standards), physical examination, and clinical laboratory and auxiliary tests during the screening period must be normal or judged by the investigator to have no clinical significance if abnormal.
Who cannot join
- Known allergy to the investigational product (including excipients or similar drugs), or individuals with a history of severe allergic diseases or considered allergic constitution (e.g., allergies to two or more drugs, foods, or pollen) as judged by the investigator to potentially compromise participant safety.
- Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).
- History of clinically severe diseases within the 6 months (180 days) prior to screening that remain unresolved, or current acute or chronic illnesses that may significantly affect the metabolism or safety evaluation of the investigational product.
- History of autoimmune diseases or chronic hepatitis.
- History of seizures, epilepsy, psychiatric or neurological disorders, or family history of seizures or epilepsy.
- Major surgery within the 3 months (90 days) prior to screening, or surgery that may significantly affect the metabolism or safety evaluation of the investigational product.
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- Previous vaccination with human rabies vaccine, or suspected history of rabies exposure (defined as bites, scratches, licks on mucous membranes or broken skin by rabid, suspected rabid, or undetermined rabies status animals, or direct contact of open wounds or mucous membranes with saliva or tissues potentially containing rabies virus), as determined by inquiry.
- Positive screening for anti-rabies virus antibodies during the screening period.
- Vaccination with any vaccine other than the rabies vaccine within the 1 month (30 days) prior to screening.
- Use of other antibody-based drugs or immunoglobulins within the 3 months (90 days) prior to screening.
- Use of passive immunizing agents, immunosuppressants, or corticosteroids within the 3 months (90 days) prior to screening.
- Use of medications that may affect the metabolism or safety evaluation of the investigational product within the 14 days prior to screening or ongoing use of such medications.
- Participation in any clinical trial involving the use of investigational drugs or devices within the 3 months (90 days) prior to screening, or planned participation in other clinical trials during this study.
- Regular alcohol consumption within the 3 months (90 days) prior to screening, averaging more than 2 alcohol units per day (1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% spirits, or 147 mL of 12% wine), or inability to abstain from alcohol during the trial period.
- Smoking habit within the 3 months (90 days) prior to screening (more than 5 cigarettes or equivalent tobacco per day), or inability to abstain from smoking during the trial period.
- Blood loss/donation exceeding 300 mL (excluding physiological blood loss in females) within the 3 months (90 days) prior to screening, receipt of blood transfusions or blood products, or plans to donate blood within 1 month (30 days) after the trial.
- Inability to avoid strenuous exercise within 14 days after dosing.
- History of drug abuse.
- Pregnant or breastfeeding women.
- History of needle or blood phobia, poor vascular condition, or intolerance to venipuncture.
- Participants who may be unable to cooperate in completing the study for other reasons or are deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Lanzhou Institute of Biological Products Co., Ltd.
Lanzhou, Gansu, 730000
Jijun Chen, +86 13919275320, chenjijun@sinopharm.com
About this study
Official title: 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
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
Read the detailed description
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:
- To evaluate the pharmacokinetics (PK) of the anti-rabies mAb administered alone or in combination with a human rabies vaccine in healthy adult participants aged 18-60.
- To evaluate the incidence of anti-drug antibodies for the anti-rabies mAb compared to human rabies immune globulin, administered alone or in combination with a human rabies vaccine, in healthy adult participants aged 18-60.
- To provide a basis for dose selection for Phase III clinical studies.
- Conditions
- Rabies (Healthy Volunteers)
- Being tested
- Recombinant Human Rabies Virus Monoclonal Antibody Injection, Human Rabies Immunoglobulin (HRIG), Placebo, Rabies Vaccine
- Keywords
- Recombinant Human, Rabies, Monoclonal Antibody
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Rabies Virus Monoclonal Antibody InjectionDrug
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.
Human Rabies Immunoglobulin (HRIG)Drug
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.
PlaceboDrug
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.
Rabies VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1：40 IU/kg monoclonal antibody - Monotherapy Study | Experimental | 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). Receives: Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection |
| Group 2: 80 IU/kg monoclonal antibody - Monotherapy Study | Experimental | 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). Receives: Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection |
| Group 3: HRIG (20 IU/kg) group - Monotherapy Study | Experimental | 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). Receives: Drug: Human Rabies Immunoglobulin (HRIG) |
| Group 4：40 IU/kg monoclonal antibody plus vaccine - Combined Administration Study | Experimental | 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). Receives: Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection; Biological: Rabies Vaccine |
| Group 5：80 IU/kg monoclonal antibody plus vaccine - Combined Administration Study | Experimental | 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). Receives: Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection; Biological: Rabies Vaccine |
| Group 6: HRIG (20 IU/kg) plus vaccine - Combined Administration Study | Experimental | 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). Receives: Drug: Human Rabies Immunoglobulin (HRIG); Biological: Rabies Vaccine |
| Group 7: placebo plus vaccine - Combined Administration Study | Experimental | 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). Receives: Drug: Placebo; Biological: Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 0-105 days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Tympanic temperature（℃）
Measured: 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）
Measured: 0-105 Days
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Pulse（bpm）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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（%）
Measured: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Protein（g/L）
Measured: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Glucose（mmol/L）
Measured: 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）
Measured: 0-105 Days
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Urine Erythrocytes （/μL）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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.
Measured: 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.
Measured: 0-105 Days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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-∞.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 105 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start31 Jan 2026 (estimated)
- Primary completion29 Jul 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies (Healthy Volunteers)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chaolin Huang, Principal investigator, Wuhan Jinyintan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445815
- Sponsor's protocol ID
- CNBG-CT-0282
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07445815
- Acronym / sponsor ID
- CNBG-CT-0282
- Conditions
- Rabies (Healthy Volunteers)
- Keywords
- Recombinant Human, Rabies, Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 29 Jul 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- To evaluate the pharmacokinetics (PK) of the anti-rabies mAb administered alone or in combination with a human rabies vaccine in healthy adult participants aged 18-60.
- To evaluate the incidence of anti-drug antibodies for the anti-rabies mAb compared to human rabies immune globulin, administered alone or in combination with a human rabies vaccine, in healthy adult participants aged 18-60.
- To provide a basis for dose selection for Phase III clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1：40 IU/kg monoclonal antibody - Monotherapy Study | Experimental | Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection60 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). |
| Group 2: 80 IU/kg monoclonal antibody - Monotherapy Study | Experimental | Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection60 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). |
| Group 3: HRIG (20 IU/kg) group - Monotherapy Study | Experimental | Drug: Human Rabies Immunoglobulin (HRIG)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). |
| Group 4：40 IU/kg monoclonal antibody plus vaccine - Combined Administration Study | Experimental | Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection, Biological: Rabies VaccineA 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). |
| Group 5：80 IU/kg monoclonal antibody plus vaccine - Combined Administration Study | Experimental | Drug: Recombinant Human Rabies Virus Monoclonal Antibody Injection, Biological: Rabies VaccineA 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). |
| Group 6: HRIG (20 IU/kg) plus vaccine - Combined Administration Study | Experimental | Drug: Human Rabies Immunoglobulin (HRIG), Biological: Rabies VaccineA 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). |
| Group 7: placebo plus vaccine - Combined Administration Study | Experimental | Drug: Placebo, Biological: Rabies VaccineA 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification.
- Participants voluntarily agree to participate in the study and sign an informed consent form.
- Female participants must have no plans for pregnancy or egg donation from 14 days prior to dosing until 6 months after dosing and must voluntarily adopt effective physical contraceptive measures. Male participants must have no plans for pregnancy or sperm donation within 6 months after dosing and must voluntarily adopt effective physical contraceptive measures.
- Female participants must weigh ≥45.0 kg and ≤80.0 kg, and male participants must weigh ≥50.0 kg and ≤80.0 kg. Body mass index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight in kg / height in m²).
- Vital signs (reference ranges: systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-100 beats per minute, all inclusive; body temperature assessed by the investigator according to the research center's standards), physical examination, and clinical laboratory and auxiliary tests during the screening period must be normal or judged by the investigator to have no clinical significance if abnormal.
Key exclusion criteria (21 listed)
- Known allergy to the investigational product (including excipients or similar drugs), or individuals with a history of severe allergic diseases or considered allergic constitution (e.g., allergies to two or more drugs, foods, or pollen) as judged by the investigator to potentially compromise participant safety.
- Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).
- History of clinically severe diseases within the 6 months (180 days) prior to screening that remain unresolved, or current acute or chronic illnesses that may significantly affect the metabolism or safety evaluation of the investigational product.
- History of autoimmune diseases or chronic hepatitis.
- History of seizures, epilepsy, psychiatric or neurological disorders, or family history of seizures or epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Rabies Virus Monoclonal Antibody InjectionOn 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. | Drug | Group 1：40 IU/kg monoclonal antibody - Monotherapy Study, Group 2: 80 IU/kg monoclonal antibody - Monotherapy Study, Group 4：40 IU/kg monoclonal antibody plus vaccine - Combined Administration Study, Group 5：80 IU/kg monoclonal antibody plus vaccine - Combined Administration Study |
| Human Rabies Immunoglobulin (HRIG)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. | Drug | Group 3: HRIG (20 IU/kg) group - Monotherapy Study, Group 6: HRIG (20 IU/kg) plus vaccine - Combined Administration Study |
| PlaceboOn 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. | Drug | Group 7: placebo plus vaccine - Combined Administration Study |
| Rabies VaccineOn 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. | Biological | Group 4：40 IU/kg monoclonal antibody plus vaccine - Combined Administration Study, Group 5：80 IU/kg monoclonal antibody plus vaccine - Combined Administration Study, Group 6: HRIG (20 IU/kg) plus vaccine - Combined Administration Study, Group 7: placebo plus vaccine - Combined Administration Study |
Primary outcome
Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.
Time frame: At least 30 minutes after administration
Local and systemic adverse events (AEs)
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.
Time frame: 0-105 days
Local AEs, systemic AEs, and serious adverse events (SAEs)
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Time frame: 0-105 Days
Tympanic temperature（℃）
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Time frame: 0-105 Days
Systolic Pressure and Diastolic Pressure (Sitting Position) （mmHg）
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Time frame: 0-105 Days
Pulse（bpm）
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
12-lead electrocardiogram（Heart Rate，bpm）
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
12-lead electrocardiogram（ Heart Rhythm）
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
12-lead electrocardiogram（ST Segment，mV）
Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
12-lead electrocardiogram（Abnormal Q Wave，ms）
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Chest X-ray（Cardiothoracic Ratio，>0.5）
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Chest X-ray（Pulmonary Nodule Size，mm）
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Chest X-ray（Costophrenic Angle，cm）
Changes in chest X-ray findings from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Chest X-ray（Tracheal Position，cm）
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
White Blood Cell Count（×10⁹/L）
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Hemoglobin（g/L）
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Platelet Count（×10⁹/L）
Changes in complete blood count (CBC) results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Neutrophil Percentage（%）
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Protein（g/L）
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Glucose（mmol/L）
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
White Blood Cells in Urine（/μL）
Changes in urinalysis results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Urine Erythrocytes （/μL）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Blood Glucose （mmol/L）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Potassium （mmol/L）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Creatinine （µmol/L）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Alanine Aminotransferase（U/L）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
Sodium（mmol/L）
Changes in blood biochemistry results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 Days
estimated Glomerular Filtration Rate（mL/min/1.73m²）
Changes in routine coagulation test results from baseline at different observation time points following administration of the investigational product/vaccine.
Time frame: 0-105 days
Prothrombin Time（s）
Pharmacodynamic Endpoints
Time frame: 0-105 Days
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.
Pharmacodynamic Endpoints
Time frame: 0-105 Days
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.
11 secondary outcomes
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Pharmacokinetic Endpoints
Time frame: 105 Days
Anti-drug Antibodies (ADA)
Time frame: 105 Days
Anti-drug Antibodies (ADA)
Time frame: 105 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Rabies (Healthy Volunteers)
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Rabies (Healthy Volunteers)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaolin Huang principal investigator
Wuhan Jinyintan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Rabies Virus Monoclonal Antibody Injection, Human Rabies Immunoglobulin (HRIG) and Rabies Vaccine in people with Rabies (Healthy Volunteers), run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jijun Chen (+86 13919275320, chenjijun@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine. (time frame: At least 30 minutes after administration). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.