A Phase 1 interventional study of Peginterferon Beta-1a in Healthy, sponsored by Biogen. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-09.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.
Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe
Biological: Peginterferon Beta-1a
A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe
Biological: Peginterferon Beta-1a
As specified in the treatment arm
Also known as: Plegridy, BIIB017
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Up to 240 hours post-dose
Maximum observed serum concentration (Cmax) of Peginterferon Beta-1a
Time frame: Up to 240 hours post-dose
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 29
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Biogen