A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration

NCT02573025 | Completed Phase 1

• 1 other identifier: YV29573
• Study Type: interventional
• Target: 277
• Locations: 5 countries
• Sites: 9

Brief Summary

This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a \[Pegasys®\]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a

  Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose

• Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h)

  Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose

Secondary Outcomes (4)

• Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)

  Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose

• Time to Reach Cmax (tmax) for PEG-IFN alfa-2a

  Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose

• Terminal Half-Life (t1/2) for PEG-IFN alfa-2a

  Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose

• Percentage of Participants With Adverse Events

  Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)

Study Arms (2)

Test Followed by Reference

EXPERIMENTAL

Participants will receive PEG-IFN alfa-2a BA-free formulation (Test) in Period 1, followed by PEG-IFN alfa-2a market formulation (Reference) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.

Drug: PEG-IFN alfa-2a BA-free formulation (Test); Drug: PEG-IFN alfa-2a market formulation (Reference)

Reference Followed by Test

EXPERIMENTAL

Participants will receive PEG-IFN alfa-2a market formulation (Reference) in Period 1, followed by PEG-IFN alfa-2a BA-free formulation (Test) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.

Drug: PEG-IFN alfa-2a BA-free formulation (Test); Drug: PEG-IFN alfa-2a market formulation (Reference)

Interventions

PEG-IFN alfa-2a BA-free formulation (Test) DRUG

Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Reference Followed by Test; Test Followed by Reference

PEG-IFN alfa-2a market formulation (Reference) DRUG

Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Also known as: Pegasys

Reference Followed by Test; Test Followed by Reference

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male Chinese participants
• Body mass index between 19 and 28 kilograms per square meter (kg/m\^2), inclusive
• Participants determined as healthy by their medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory measurements performed at the Screening visit
• Female participants of childbearing potential: willing to use highly effective methods of contraception throughout the study and for 90 days after the last dosing
• Male participants: agreement to remain abstinent or use spermicide and barrier method contraception throughout the study and for 90 days after the last dosing
• Able to participate and willing to give written informed consent and to comply with the study restrictions

You may not qualify if:

• Any clinically relevant condition or history of cardiovascular, psychiatric, gastrointestinal, respiratory, renal, hepatic, hematological, lymphatic, neurological (including seizure history), musculoskeletal, genitourinary, immunological, metabolic, malignant, or dermatological disorder
• Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) or human immunodeficiency virus I and II antibody (anti-HIV I, anti-HIV II) tests at Screening
• Participants with alanine aminotransferase (ALT) above the upper limit of normal at Screening or on Day -1 of Period 1
• Any other condition or disease (other than those already stated) which, in the judgment of the Investigator, would place the participant at undue risk, interfere with the absorption, distribution, metabolism, and excretion of PEG-IFN alfa-2a, or interfere with the ability of the participant to complete the study
• History of drug or alcohol abuse within the last year before screening
• Treatment with interferon or PEG-IFN alfa-2a within 3 months prior to the first dosing
• Female participants who are pregnant, currently lactating, or have a positive serum pregnancy test at screening or have a positive urine pregnancy test on Day -1 of Period 1
• Use of any prescribed or over the counter medication or herbal medicine taken within 14 days prior to the first dosing or within 5 times the elimination half-life of the medication prior to the first dosing (whichever is longer). Exceptions are paracetamol, the contraceptive pill, hormone replacement therapy and commonly used vitamin supplements, which are permitted
• Regular smoking with consumption of more than 10 cigarettes per day or an equivalent amount of tobacco
• Participation in an investigational drug or device study within 3 months prior to the first dosing

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

CMAX A division of IDT Australia Limited

Adelaide, South Australia, 5000, Australia

Location

The University of Hong Kong; Pharmacy Clinical Trials

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong; Emergency Medicine

Shatin, 00000, Hong Kong

Location

Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

Auckland Clinical Studies Limited

Grafton, 1010, New Zealand

Location

SingHealth Investigational Medicine Unit; Haematology

Singapore, 169608, Singapore

Location

Changi General Hospital- Parent; Department of Rheumatology

Singapore, 529889, Singapore

Location

China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

Taichung, 404, Taiwan

Location

Taipei Medical University Hospital; Clinical Research Center

Taipei, 110, Taiwan

Location

MeSH Terms

Interventions

peginterferon alfa-2a

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 9, 2015
• Study Start: September 17, 2015
• Primary Completion: April 11, 2016
• Study Completion: April 11, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

NZ (2); HK (2); AU (1); TW (2); SG (2)