Multiple Sclerosis Clinical Trial
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
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.
Full 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:
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.
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There is 1 Location for this study
St. Paul Minnesota, , United States
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