Research Site
Saint Paul, Minnesota, United States
NCT Number: NCT01610310
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Saint Paul, Minnesota, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Other names: BIIB017
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other names: BIIB017
Time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
Time frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
Time frame: Day 1 up to Day 50
Time frame: Day 1 up to Day 50
Time frame: Day 1 up to Day 50)
Time frame: Day 1 up to Day 50
Time frame: Day 1 up to Day 50
Time frame: Days 1+2, 22+23
Biogen
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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