None. Healthy volunteers.
Conditions
Interventions
180 micrograms single dose of Peg-interferon alfa-2, of one of the formulations studied will be administered subcutaneously into the deltoid region. The formulations under study are Pegasys (Hoffman-L
Interferon-alpha
Injections, Subcutaneous
Peginterferon alpha-2
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Absence of antecedents from chronic diseases. 2. Absence of antecedents from acute diseases in the last 30 days. 3. Absence of symptoms and signs with the physical examination and laboratory test. 4. Seronegatives for HIV, hepatitis B and hepatitis C tests. 5. Voluntariness of the individual through the signing of the informed consent. 6.18-35 years of age. 7. Quetelet Index (19-29), (weight in kg, height in square meter). 8. Male.
Exclusion criteria
Exclusion criteria: 1. Personal pathological antecedents from chronic diseases. 2. Individuals who have undergone treatment with some type of interferon in the last 30 days. 3. To refer some acute viral disease in the last 30 days. 4. To be under medication that can alter immunity. 5. Antecedents of allergy, idiosyncracy or hypersensitivity to a drug. 6. Surgery during the 6 previous months to the study initiation. 7. Blood donation three months before the study initiation. 8. Antecedents of alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| “Serum levels of pegylated IFN by EIA” and “Antiviral activity of the pegylated IFN” variables, measurement time: 336 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ''Beta-2 micro globulin'', “2',5'-oligoadenylate synthetase'', and ''neopterin'' variables, measurement time: 336 hours. 2. “Safety of the treatment” variable, measurement time: 336 hours. | — |
Countries
Cuba
Contacts
Public ContactIdrian García García
Center for Genetic Engineering and Biothecnology (CIGB)
Outcome results
None listed