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AzTrials

Healthy VolunteersPhase 1NCT02573025

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 study testing PEG-IFN alfa-2a BA-free formulation (Test) and PEG-IFN alfa-2a market formulation (Reference) in people with Healthy Volunteers, run by Hoffmann-La Roche at 9 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PEG-IFN alfa-2a BA-free formulation (Test) and PEG-IFN alfa-2a market formulation (Reference)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
9 sitesin 5 countries
Study dates
17 Sep 2015to 11 Apr 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

9 sites in 5 countries.

9 sites in 5 countries

Hong Kong2 sites

  • The University of Hong Kong; Pharmacy Clinical Trials

    Hong Kong

  • The Chinese University of Hong Kong; Emergency Medicine

    Shatin, 00000

Other trials in Hong Kong

New Zealand2 sites

  • Christchurch Clinical Studies Trust

    Christchurch, 8011

  • Auckland Clinical Studies Limited

    Grafton, 1010

Other trials in New Zealand

Singapore2 sites

  • SingHealth Investigational Medicine Unit; Haematology

    Singapore, 169608

  • Changi General Hospital- Parent; Department of Rheumatology

    Singapore, 529889

Other trials in Singapore

Taiwan2 sites

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

    Taichung, 404

  • Taipei Medical University Hospital; Clinical Research Center

    Taipei, 110

Other trials in Taiwan

Australia1 site

  • CMAX A division of IDT Australia Limited

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: An Open-Label, Randomized, Multi-Center, Single Dose, Two-Period, Two Sequence Crossover Study to Investigate the Bioequivalence of Peginterferon (PEG-IFN) Alfa-2a Benzyl Alcohol-Free Formulation Versus the Reference Market Formulation Following Subcutaneous Administration Via Prefilled Syringe in Healthy Chinese Subjects

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.

Being tested
PEG-IFN alfa-2a BA-free formulation (Test), PEG-IFN alfa-2a market formulation (Reference)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • PEG-IFN alfa-2a market formulation (Reference)Drug

    Also called Pegasys

    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).

Study groups in NCT02573025
Study groupRoleWhat they receive
Test Followed by ReferenceExperimentalParticipants 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.
Receives: Drug: PEG-IFN alfa-2a BA-free formulation (Test); Drug: PEG-IFN alfa-2a market formulation (Reference)
Reference Followed by TestExperimentalParticipants 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.
Receives: Drug: PEG-IFN alfa-2a BA-free formulation (Test); Drug: PEG-IFN alfa-2a market formulation (Reference)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

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

    Measured: 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)

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

    Measured: 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

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

    Measured: 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

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

    Measured: 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

  4. Percentage of Participants With Adverse Events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completion11 Apr 2016
  4. Study completion11 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573025
Sponsor's protocol ID
YV29573
Status last verified
Mar 2017
First submitted
8 Oct 2015
Last updated
13 Mar 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEG-IFN alfa-2a BA-free formulation (Test) and PEG-IFN alfa-2a market formulation (Reference) in people with Healthy Volunteers, run by Hoffmann-La Roche at 9 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Hong Kong, New Zealand, Singapore, Taiwan, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.

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