Healthy
Conditions
Brief summary
The primary objectives are to identify the highest safe and well-tolerated dose and frequency of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188 mcg, when given every other week or every 4 weeks to healthy volunteers (HV).
Interventions
DRUGBIIB017 (PEGylated Interferon Beta-1a)
Each participant will receive BIIB017 every other week or every 4 weeks.
DRUGPlacebo
Each participant will receive placebo every other week or every 4 weeks.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive, and a minimum body weight of 50.0 kg at screening. * All male subjects and female subjects of child-bearing potential must be willing and able to practice effective birth control during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Key
Exclusion criteria
* Abnormal screening and baseline blood and urine tests determined to be clinically significant by the Investigator. * Hematologic or hepatic enzyme laboratory values that were outside the normal range. * History of severe allergic or anaphylactic reactions. * History of any clinically-significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, and/or history of seizure disorder. * A family history of MS in a first-degree relative. * A fever (body temperature \>38°C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to Day 1. * Abnormal ECG values as determined by the Investigator. * Positive test result for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody. * Female subjects who are considering pregnancy, currently pregnant or breastfeeding. * Subjects who received a tattoo or body piercing (including earring) within 60 days of baseline or subjects who are considering getting a tattoo or body piercing (including earring) in the next 60 days. * Use of any prescription or non-prescription medication that could inhibit bone marrow or liver function. * Any previous treatment with any interferon product. * Participation in any other investigational drug study within the 4 weeks prior to Day 1 or within 5 half-lives of the investigational treatment, whichever is longer. * Treatment with the Flu Vaccine within 1 week prior to Day 1. NOTE: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician assessment of temperature at the injection site will be assessed on a scale of 0 to 2, where 0 represents normal temperature and 2 represents hot. | Up to Day 71 |
| The number of participants that experience Adverse Events (AEs) | Up to Day 71 |
| The number of participants that experience flu-like symptoms | Up to Day 71 |
| Participant assessment of injection site pain as measured by scores on a scale of 0 to 10, where 0 is no pain and 10 is extremely painful. | Up to Day 71 |
| Clinician assessment of the injection site for erythema as assessed by a scale 0 to 3, where 0 represents no erythema and 3 represents severe erythema | Up to Day 71 |
| Clinician assessment of the injection site for induration as assessed by a scale 0 to 3, where 0 represents no induration and 3 represents severe induration | Up to Day 71 |
| Clinician assessment of tenderness to digital pressure at the injection site will be assessed on a scale of 0 to 3, where 0 represents no tenderness and 3 represents severe tenderness | Up to Day 71 |
Secondary
| Measure | Time frame |
|---|---|
| AUC168h, area under the concentration-time curve | Up to 168 hours post dose |
| Cmax, observed maximum serum concentration | Up to 336 hours post-dose |
| Tmax, time to reach maximum serum concentration | Up to 336 hours post-dose |
| Terminal t½, half-life of the terminal phase | Up to 336 hours post-dose |
| EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose | Up to 336 hours post-dose |
| Emax, the peak concentration observed minus baseline concentration | Day 1 and Day 29 |
| PD parameters of serum concentrations of neopterin | Day 1 and Day 29 |
Countries
United States
Outcome results
None listed