A Multiple Dose Safety Study of PEG-IFN in Healthy Volunt... | NCT02125578

NCT02125578

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIIB017 (PEGylated Interferon Beta-1a)	Experimental	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)
BIIB017 (PEGylated Interferon Beta-1a) and Placebo	Experimental	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	Placebo Comparator	Placebo dose will be administered SC every other week for a total of 6 weeks.	Drug: BIIB017 (PEGylated Interferon Beta-1a)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIIB017 (PEGylated Interferon Beta-1a)	Drug	Each participant will receive BIIB017 every other week or every 4 weeks.	BIIB017 (PEGylated Interferon Beta-1a) BIIB017 (PEGylated Interferon Beta-1a) and Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Measure	Description	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

Eligibility Module

Eligibility 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/exclusion Criteria May Apply

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21680782	Result	Hu X, Miller L, Richman S, Hitchman S, Glick G, Liu S, Zhu Y, Crossman M, Nestorov I, Gronke RS, Baker DP, Rogge M, Subramanyam M, Davar G. A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology. J Clin Pharmacol. 2012 Jun;52(6):798-808. doi: 10.1177/0091270011407068. Epub 2011 Jun 16.