A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIIB017 (PEGylated Interferon Beta-1a); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125578

105HV102

Details and patient eligibility

About

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).

Enrollment: 69 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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69 participants in 3 patient groups, including a placebo group

BIIB017 (PEGylated Interferon Beta-1a)

Experimental group

Description:

Varying doses (63 mcg up to 188 mcg) of BIIB017 will be administered SC every other week for a total of 6 weeks.

Treatment:

Drug: BIIB017 (PEGylated Interferon Beta-1a)

BIIB017 (PEGylated Interferon Beta-1a) and Placebo

Experimental group

Description:

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.

Treatment:

Drug: BIIB017 (PEGylated Interferon Beta-1a)

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo dose will be administered SC every other week for a total of 6 weeks.

Treatment:

Drug: BIIB017 (PEGylated Interferon Beta-1a)