Not Yet RecruitingPhase 2

A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody

China200 participantsStarted 2026-01-31

Plain-language 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.

Timeframe: 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.

Timeframe: 0-105 days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Trial details

NCT IDNCT07445815

SponsorLanzhou Institute of Biological Products Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-29

Contact for this trial

Jijun Chen

+86 13919275320 chenjijun@sinopharm.com

View on ClinicalTrials.gov More Rabies (Healthy Volunteers) trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

What they're measuring

Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.

Timeframe: 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.

Timeframe: 0-105 days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.

Timeframe: 0-105 Days

Changes in 12-lead electrocardiogram findings from baseline at different observation time points following administration of the investigational product/vaccine.

Timeframe: 0-105 Days