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Completed

NCT Number: NCT01610310

Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers

The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Saint Paul, Minnesota, United States

About this study

This is a randomized, open-label, 2-sequence, 2-period crossover study that will be conducted at a single site in the United States to characterize the PK profile, safety and tolerability of peginterferon beta-1a delivered by autoinjector or PFS. Participants will be randomized in a 1:1 ratio to receive a single dose of peginterferon beta-1a at Day 1 delivered by either autoinjector or PFS, followed by a single dose of peginterferon beta 1a delivered by the other device at Day 22. The total duration of study participation is up to 3 months for each participant. Participants will complete a follow-up visit at Day 50 after the end of treatment period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive, and a minimum body weight of 50.0 kg

Key Exclusion Criteria:

  • History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
  • Female subjects who are pregnant or breastfeeding
  • Any previous treatment with prescription or investigational pegylated drugs.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

Device

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22

Other names: BIIB017

BIIB017 (peginterferon beta-1a) Autoinjector

Device

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

Other names: BIIB017

Primary outcomes

  1. Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)

    Time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22

Secondary outcomes

  1. Maximum Serum Concentration (Cmax) of peginterferon beta-1a

    Time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22

  2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 50

  3. Changes in clinical laboratory assessments

    Time frame: Day 1 up to Day 50

  4. Vital sign changes

    Time frame: Day 1 up to Day 50)

  5. Physical exam changes

    Time frame: Day 1 up to Day 50

  6. Electrocardiogram changes

    Time frame: Day 1 up to Day 50

  7. Clinician injection site assessment

    Time frame: Days 1+2, 22+23

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2012
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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