FarmaPEG-I
- Conditions
- one. Healthy volunteers.Healthy Volunteers
- Registration Number
- RPCEC00000039
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum levels of pegylated IFN by EIA” and Antiviral activity of the pegylated IFN” variables, measurement time: 336 hours.
- Secondary Outcome Measures
Name Time Method 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.