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
Sponsor study identifier
interventional
55
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2012
Actual (reported)June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 4, 2012
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)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
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
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.
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.
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Research Site
Saint Paul, Minnesota, United States
Medical Director
Biogen
55 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2012
First Posted
June 4, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
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
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
June 13, 2014
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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