Health Condition 1: null- Prevention of rabies
Conditions
Interventions
Intervention1: SII RMab: Human IgG1 monoclonal antibody: One time intramuscular administration at various dose levels which are 1 IU/kg, 3IU/kg, 10IU/kg, 20IU/kg, 40 IU/kg.
Control Intervention1: HRIG
is a sterile solution of antirabies immunoglobulin (10-18% protein). The dose of 20 IU/kg will be administered intramuscularly in the lateral thigh.
Sponsors
Serum Institute of India Ltd Pune India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be > or equal 18 years of age and 2. Free of obvious health problems as established by medical history and screening evaluations including clinical examination 3. Non-smoker for at least 6 months 4.A woman must agree not to become pregnant and a man must agree not to conceive a child from the time of study enrollment until at least 1 year for women and three months for men after the completion of the injections. 5. Screening laboratory values must be in normal range.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of monoclonal antibody (whether licensed or investigational). 2.Previous receipt of rabies immune globulin and /or rabies vaccine. 3.History of potential rabies exposure. 4.Chronic administration of immunosuppressants or other immune- modifying agents within six months prior to administration of study medications. 5.Acute febrile illness or acute infectious disease. 6.Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives 7. Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction. 9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen 10.Positive urine pregnancy test during screening or within 24 hours of day 0 injection, or an unwillingness to undergo pregnancy testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the investigational productTimepoint: Day 0 through day 365. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentrations and neutralizing activity of antibodies to rabies.Timepoint: Day 0 through day 365. | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd.
Outcome results
None listed