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CompletedNCT01978652Updated Jan 9, 2015

Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.

A Phase 1 interventional study of Peginterferon Beta-1a in Healthy, sponsored by Biogen. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-09.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Must have a BMI of 19 to 29 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and at Baseline.
  • Japanese subjects must have been born in Japan and have both parents and grandparents of Japanese origin. Additionally, Japanese subjects should have lived outside of Japan for less than 5 years and maintained a similar diet since leaving Japan (to be verified by a questionnaire at Screening).
  • Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment.
  • Non smoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes (or equivalent) per day throughout the remainder of the study.
  • Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.

Key Exclusion Criteria:

  • Known history of, or positive test result at Screening for human immunodeficiency virus (HIV).
  • Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg]).
  • Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured or subjects with cervical cancer stage 0 if completely excised).
  • History of severe allergic or anaphylactic reactions in the opinion of the Investigator.
  • Known allergy to any interferon or any component of BIIB017.
  • History of suicidal ideation or an episode of clinically significant depression (as determined by the Investigator) within 3 months prior to Day 1.
  • Any previous treatment with prescription or investigational pegylated drugs. The prior use of over-the-counter pegylated products, including cosmetics, is allowed.
  • Previous treatment with any interferon product.
  • History of hypersensitivity or intolerance to paracetamol, ibuprofen, or naproxen, that would preclude use of at least 1 of these during the study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Peginterferon Beta-1a administered to Japanese participants

    A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe

    Biological: Peginterferon Beta-1a

  • Experimental
    Peginterferon Beta-1a administered to Caucasian participants

    A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe

    Biological: Peginterferon Beta-1a

Interventions

  • BiologicalPeginterferon Beta-1a

    As specified in the treatment arm

    Also known as: Plegridy, BIIB017

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve from time zero to infinity (AUC0-∞)

    Time frame: Up to 240 hours post-dose

Secondary outcomes

  1. Maximum observed serum concentration (Cmax) of Peginterferon Beta-1a

    Time frame: Up to 240 hours post-dose

  2. Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to Day 29

07

Study locations

1 site
  • Research Site
    Leeds, West Yorkshire LS2 9LH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01978652
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Nov 7, 2013
Start date
Dec 2013
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Jan 9, 2015

Study contacts

Medical Director
study director · Biogen
View the source record on ClinicalTrials.gov ↗

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