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
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| City: |
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St. Paul |
| State: |
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Minnesota |
| Zip Code: |
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| Conditions: |
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Healthy Volunteers - Multiple Sclerosis |
| Purpose: |
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The purpose of this study is to characterize the PK profile, safety, and tolerability of
peginterferon beta-1a delivered by the single-use autoinjector or prefilled syringe (PFS) in
healthy volunteers to support the development of the autoinjector.
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| Study Summary: |
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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. Subjects 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 subject. Subjects will complete a follow-up visit at Day 50 after the end
of treatment period.
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| Criteria: |
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Inclusion Criteria:
1. Must be healthy males or females between 18 to 45 years old, inclusive.
2. Must have a body mass index (BMI) of 19 to 29 kg/m2, inclusive, and a minimum body
weight of 50.0 kg
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.
Other protocol-defined inclusion/exclusion criteria may apply.
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| NCT ID: |
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NCT01610310 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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St. Paul, Minnesota
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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