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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy, Multiple Sclerosis

Intervention / Treatment
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* Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
* Device: BIIB017 (peginterferon beta-1a) Autoinjector


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peginterferon beta-1a PFS/autoinjector<br>A single dose of peginterferon beta-1a 125 mcg administered by prefilled syringe (PFS) on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by autoinjector on Day 22. | Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)<br>* 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22<br>* Other names: BIIB017;Device: BIIB017 (peginterferon beta-1a) Autoinjector<br>* 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22<br>* Other names: BIIB017;|
| Experimental: peginterferon beta-1a autoinjector / PFS<br>A single dose of peginterferon beta-1a 125 mcg administered by autoinjector on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by prefilled syringe (PFS) on Day 22. | Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)<br>* 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22<br>* Other names: BIIB017;Device: BIIB017 (peginterferon beta-1a) Autoinjector<br>* 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22<br>* Other names: BIIB017;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞) |  | For 11 days (multiple timepoints) after each dose on Day 1 and 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Serum Concentration (Cmax) of peginterferon beta-1a |  | For 11 days (multiple timepoints) after each dose on Day 1 and 22 | 
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 50 | 
| Changes in clinical laboratory assessments |  | Day 1 up to Day 50 | 
| Vital sign changes |  | Day 1 up to Day 50) | 
| Physical exam changes |  | Day 1 up to Day 50 | 
| Electrocardiogram changes |  | Day 1 up to Day 50 | 
| Clinician injection site assessment |  | Days 1+2, 22+23 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable, MS