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Preliminary assessment of dose tolerance, safety, pharmacokinetics and neutralizing antibodies to rhRIG

Preliminary assessment of dose tolerance, safety, pharmacokinetics and neutralizing antibodies to rhRIG

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023809
Enrollment
Unknown
Registered
2019-06-13
Start date
2010-07-08
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Interventions

Low dose group:Test preparation
Medium dose group:Test preparation
High dose group:Test preparation
Placebo group:excipient

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy adults aged 18-45, who have informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. It is considered that the requirements of the clinical trial program cannot be complied with; 2. Have bad habits of alcoholism; 3. The urine pregnancy test results are positive; 4. Lactating women; 5. Questioned medical history, physical examination, heart, liver, kidney, blood, digestive tract, nervous system, mental disorders and metabolic abnormalities; 6. Have a history of drug allergy, especially allergic to vaccines, serum, immunoglobulins, antibodies and other biological agents; 7. Physical examination showed blood pressure, heart rate, electrocardiogram, respiratory status, liver, kidney function and abnormal blood; 8. The weight exceeds the range of ±10% of the standard weight; 9. Those who have been vaccinated with rabies (positive serum antibody test results); 10. Vaccination products such as immunoglobulins are inoculated within one month before the test; 12. Any medication used within two weeks; 13. Allergic to any constituent of the research product; 14. Known immunological function damage; 15. Known active infections (such as hepatitis B, hepatitis C, HIV infection); 16. Any situation that the investigator believes may affect the evaluation of the trial.

Design outcomes

Primary

MeasureTime frame
Antibody concentration;Antibody neutralization activity;

Countries

China

Contacts

Public ContactMeixia Wang

Beijing You'an Hospital, Capital Medical University

wangmeixiad@163.com+86 13811117487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026