Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers

Inclusion Criteria:

• No history of chronic diseases;
• Preserved oral health;
• No history of acute illness in the last 30 days;
• Absence of significant clinical symptoms and signs on physical examination;
• laboratory tests within normal limits;
• imaging tests within normal limits;
• Seronegative tests for HIV and B and C Hepatitis; Signing the consent form;
• Male;
• Age between 18 and 35 years;
• Body mass index between 19 and 26 (weight in kg / height in meters squared).

Exclusion Criteria:

• Patients with hypersensitivity to Interferon alpha, Escherichia coli-derived products, polyethylene glycol (macrogol), or any constituent salts of these preparations.
• Individuals treated with some type of interferon at any time, prior to the present research.
• History of chronic diseases such as autoimmune diseases, liver failure, decompensated cirrhosis, heart disease, renal failure, diabetes mellitus, thyroid diseases, hemoglobinopathies, cytopenias, history of psychiatric disease, retinopathy, optic neuritis.
• History of acute viral disease in the last 30 days;
• Current use of medications that alter immunity: corticosteroids, immunosuppressants;
• History of known allergy to drugs, including interferon or to any component of the product (at the discretion of the investigator);
• Having undergone surgery during the 6 months prior to study entry; Had donated blood three months prior to study entry;
• History of alcoholism or current use of alcohol;
• Use of other illicit drugs in the past 6 months;
• Participation in a clinical study with previous therapeutic intervention in the year prior to inclusion.