Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in
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
What it found
We found no results in the registry or in papers.
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
- BIIB017 (peginterferon beta-1a) Autoinjector
What it measured
Main measures
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
Immune responseHow the body handles the medicine
Other measures (7)
Maximum Serum Concentration (Cmax) of peginterferon beta-1a
For 11 days (multiple timepoints) after each dose on Day 1 and 22
Immune responseHow the body handles the medicineNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 50
SafetyChanges in clinical laboratory assessments
Day 1 up to Day 50
Vital sign changes
Day 1 up to Day 50)
SafetyPhysical exam changes
Day 1 up to Day 50
Electrocardiogram changes
Day 1 up to Day 50
Clinician injection site assessment
Days 1+2, 22+23
Safety
Who could take part
MS (type not specified) · 18 to 45
Show the full criteria
Inclusion 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: 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Jun 2012
Main results due
Oct 2012
Finished
Oct 2012