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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4 weeks. The study population will be 32 healthy male volunteers to whom will be administered a single dose of 180 microgram of each product, subcutaneously. The study will have a total duration of 14 days in each treatment step. The serum concentration of PEG-interferon for both products, measured by enzyme immunoassay (EIA) and by antiviral activity of PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2 microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and neopterin) and safety evaluation, will be measured.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Treatments: Peginterferon alfa-2a; Peginterferon alfa-2b

Criteria

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.