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

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

Tracking Information
First Submitted Date  ICMJE April 25, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 29, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2014)
69
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02125578
Other Study ID Numbers  ICMJE 105HV102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP