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

Phase 1

Completed

• Conditions: Healthy; Multiple Sclerosis

• Registration Number: NCT01610310
• Lead Sponsor: Biogen

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.

Study Timeline

• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-05-31
• Study Start: 2012-06
• Study First Posted: 2012-06-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 St. Paul, Minnesota, United States