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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Ranging, Parallel-Group Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Volunteers

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIIB017 (PEGylated Interferon Beta-1a); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BIIB017 (PEGylated Interferon Beta-1a); Each participant will receive BIIB017 every other week or every 4 weeks.
Experimental: 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.	Drug: BIIB017 (PEGylated Interferon Beta-1a); Each participant will receive BIIB017 every other week or every 4 weeks.; Drug: Placebo; Each participant will receive placebo every other week or every 4 weeks.
Placebo Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• 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. Erratum In: J Clin Pharmacol. 2012 Sep;52(9):NP4-5.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: 105HV102