A Phase 1 interventional study of BIIB017 (PEGylated Interferon Beta-1a) and Placebo in Healthy, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-29.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
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).
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Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every other week for a total of 6 weeks.
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every 4 weeks for a total of 6 weeks. To ensure blinding, each subject will receive placebo every other week.
Drug: BIIB017 (PEGylated Interferon Beta-1a) · Drug: Placebo
Placebo dose will be administered SC every other week for a total of 6 weeks.
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Each participant will receive BIIB017 every other week or every 4 weeks.
Each participant will receive placebo every other week or every 4 weeks.
The number of participants that experience Adverse Events (AEs)
Time frame: Up to Day 71
The number of participants that experience flu-like symptoms
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 71
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.
Time frame: Up to Day 71
AUC168h, area under the concentration-time curve
Time frame: Up to 168 hours post dose
Cmax, observed maximum serum concentration
Time frame: Up to 336 hours post-dose
Tmax, time to reach maximum serum concentration
Time frame: Up to 336 hours post-dose
Terminal t½, half-life of the terminal phase
Time frame: Up to 336 hours post-dose
EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose
Time frame: Up to 336 hours post-dose
Emax, the peak concentration observed minus baseline concentration
Time frame: Day 1 and Day 29
PD parameters of serum concentrations of neopterin
Time frame: Day 1 and Day 29
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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