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

NCT ID: NCT01889849

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-08-31

Brief 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.

Detailed Description

Double-blind study, ie, the volunteers and the study team will not be aware of the product administered. As the presentations of the two products are different, only the professional who will administer the injections will not be blinded, and will not have contact with volunteers or members of the study team after applying the medication.

Conditions

Chronic Viral Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BIP48

Will be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step.

Group Type: EXPERIMENTAL

BIP 48

Intervention Type: DRUG

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Pegasys

Intervention Type: DRUG

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Pegasys

Will be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step.

Group Type: ACTIVE_COMPARATOR

BIP 48

Intervention Type: DRUG

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Pegasys

Intervention Type: DRUG

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Interventions

BIP 48

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Intervention Type: DRUG

Pegasys

Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Peginterferon alfa 2b 48kDA; Peginterferon alfa 2a 40kDA

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paulo Dornelles Picon, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Immunobiological Technology Institute (Bio-Manguinhos)

Locations

Bio-Manguinhos/Fiocruz

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

da Silva AMV, Alvarado-Arnez LE, Azamor T, Batista-Silva LR, Leal-Calvo T, Bezerra OCL, Ribeiro-Alves M, Kehdy FSG, Neves PCDC, Bayma C, da Silva J, de Souza AF, Muller M, de Andrade EF, Andrade ACM, Dos Santos EM, Xavier JR, Maia MLS, Meireles RP, Cuni HN, Sander GB, Picon PD, Matos DCS, Moraes MO. Interferon-lambda 3 and 4 Polymorphisms Increase Sustained Virological Responses and Regulate Innate Immunity in Antiviral Therapy With Pegylated Interferon-Alpha. Front Cell Infect Microbiol. 2021 Jul 7;11:656393. doi: 10.3389/fcimb.2021.656393. eCollection 2021.

Reference Type: DERIVED

PMID: 34307188 (View on PubMed)

Costa MB, Picon PD, Sander GB, Cuni HN, Silva CV, Meireles RP, Goes ACMA, Batoreu NM, Maia MLS, Albuquerque EM, Matos DCS, Saura PL. Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers. BMC Pharmacol Toxicol. 2018 Jan 4;19(1):1. doi: 10.1186/s40360-017-0192-z.

Reference Type: DERIVED

PMID: 29301580 (View on PubMed)

Other Identifiers

ASCLIN 003/2009

Identifier Type: -

Identifier Source: org_study_id