CompletedNCT02573025Updated Mar 13, 2017

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

A Phase 1 interventional study of PEG-IFN alfa-2a BA-free formulation (Test) and PEG-IFN alfa-2a market formulation (Reference) in Healthy Volunteers, sponsored by Hoffmann-La Roche. Completed at 9 sites in 5 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-13.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 277
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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 studied

Healthy Volunteers

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 277 participants (actual)

Study arms

Experimental
Test Followed by Reference
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)
Experimental
Reference Followed by Test
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

DrugPEG-IFN alfa-2a BA-free formulation (Test)
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).
DrugPEG-IFN alfa-2a market formulation (Reference)
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

What researchers measure

Primary outcomes

Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a
Time frame: 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)
Time frame: 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

Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)

Study locations

9 sites

CMAX A division of IDT Australia Limited
Adelaide, South Australia 5000, Australia
The University of Hong Kong; Pharmacy Clinical Trials
Hong Kong, Hong Kong
The Chinese University of Hong Kong; Emergency Medicine
Shatin, 00000, Hong Kong
Christchurch Clinical Studies Trust
Christchurch, 8011, New Zealand
Auckland Clinical Studies Limited
Grafton, 1010, New Zealand
SingHealth Investigational Medicine Unit; Haematology
Singapore, 169608, Singapore
Changi General Hospital- Parent; Department of Rheumatology
Singapore, 529889, Singapore
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
Taichung, 404, Taiwan
Taipei Medical University Hospital; Clinical Research Center
Taipei City, 110, Taiwan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02573025
Lead sponsor: Hoffmann-La Roche
Responsible party: Sponsor
First posted: Oct 9, 2015
Start date: Sep 17, 2015
Primary completion: Apr 11, 2016
Completion: Apr 11, 2016
Last update: Mar 13, 2017

Study contacts

Clinical Trials

study director · Hoffmann-La Roche

View the source record on ClinicalTrials.gov ↗

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