Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)