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

NCT01889849 | Completed Phase 1 DMC

• 1 other identifier: ASCLIN 003/2009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Viral Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  Evaluation of safety will be estimated by the analysis of clinical chemistry and hematology (CBC and transaminase) prior to study initiation and at 24, 48, 72, 96, 120, 168 and 336 hours after administration of peginterferon alpha, in each treatment period.

  14 days + least 4 weeks (rest period between each administration) + 14 days

Study Arms (2)

BIP48

EXPERIMENTAL

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.

Drug: BIP 48; Drug: Pegasys

Pegasys

ACTIVE COMPARATOR

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.

Drug: BIP 48; Drug: Pegasys

Interventions

BIP 48 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.

Also known as: Peginterferon alfa 2b 48kDA

BIP48; Pegasys

Pegasys 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.

Also known as: Peginterferon alfa 2a 40kDA

BIP48; Pegasys

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Bio-Manguinhos/Fiocruz

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34307188 DERIVED

• 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.

  PMID: 29301580 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo Dornelles Picon, Doctorate

  Immunobiological Technology Institute (Bio-Manguinhos)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 1, 2013
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

BR (1)