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

NCT ID: NCT02125578

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-05-31

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIIB017 (PEGylated Interferon Beta-1a)

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

Group Type: EXPERIMENTAL

BIIB017 (PEGylated Interferon Beta-1a)

Intervention Type: DRUG

Each participant will receive BIIB017 every other week or every 4 weeks.

BIIB017 (PEGylated Interferon Beta-1a) and Placebo

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.

Group Type: EXPERIMENTAL

BIIB017 (PEGylated Interferon Beta-1a)

Intervention Type: DRUG

Each participant will receive BIIB017 every other week or every 4 weeks.

Placebo

Intervention Type: DRUG

Each participant will receive placebo every other week or every 4 weeks.

Placebo

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

Group Type: PLACEBO_COMPARATOR

BIIB017 (PEGylated Interferon Beta-1a)

Intervention Type: DRUG

Each participant will receive BIIB017 every other week or every 4 weeks.

Interventions

BIIB017 (PEGylated Interferon Beta-1a)

Each participant will receive BIIB017 every other week or every 4 weeks.

Intervention Type: DRUG

Placebo

Each participant will receive placebo every other week or every 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21680782 (View on PubMed)

Other Identifiers

105HV102

Identifier Type: -

Identifier Source: org_study_id