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 range18 Years – 60 Years

SexALL

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.
✕. Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).

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

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

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 range18 Years – 60 Years

SexALL

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.
✕. Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).

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

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