Clinical trial NCT01610310: Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Multiple Sclerosis
Keywords: SC
PEG
Inteferon
PK
Subcutaneous
PEGylated
Autoinjector
Injectable
MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria:

1. 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:

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

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

Primary outcomes:
measure: Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)
timeFrame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of peginterferon beta-1a
timeFrame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 50
measure: Changes in clinical laboratory assessments
timeFrame: Day 1 up to Day 50
measure: Vital sign changes
timeFrame: Day 1 up to Day 50)
measure: Physical exam changes
timeFrame: Day 1 up to Day 50
measure: Electrocardiogram changes
timeFrame: Day 1 up to Day 50
measure: Clinician injection site assessment
timeFrame: Days 1+2, 22+23
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: