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

• ClinicalTrials.gov Identifier: NCT02125578
• Recruitment Status: Completed
• First Posted: April 29, 2014
• Last Update Posted: April 29, 2014
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

Tracking Information

• First Submitted Date: April 25, 2014
• First Posted Date: April 29, 2014
• Last Update Posted Date: April 29, 2014
• Study Start Date: March 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 25, 2014)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 25, 2014)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Ranging, Parallel-Group Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Volunteers
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• 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.

Study Arms

• 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.
  Intervention: Drug: BIIB017 (PEGylated Interferon Beta-1a)
• 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.
  Interventions:

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 25, 2014): 69
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02125578
• Other Study ID Numbers: 105HV102
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Biogen
• Study Sponsor: Biogen
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Biogen

• PRS Account: Biogen
• Verification Date: April 2014