Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB017 (PEGylated Interferon Beta-1a) Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The number of participants that experience Adverse Events (AEs) [ Time Frame: Up to Day 71 ]
  2. The number of participants that experience flu-like symptoms [ Time Frame: Up to Day 71 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]

Secondary Outcome Measures :
  1. AUC168h, area under the concentration-time curve [ Time Frame: Up to 168 hours post dose ]
  2. Cmax, observed maximum serum concentration [ Time Frame: Up to 336 hours post-dose ]
  3. Tmax, time to reach maximum serum concentration [ Time Frame: Up to 336 hours post-dose ]
  4. Terminal t½, half-life of the terminal phase [ Time Frame: Up to 336 hours post-dose ]
  5. EAUC-336h, area under the concentration-time curve from time zero to 336 hours post-dose [ Time Frame: Up to 336 hours post-dose ]
  6. Emax, the peak concentration observed minus baseline concentration [ Time Frame: Day 1 and Day 29 ]
  7. PD parameters of serum concentrations of neopterin [ Time Frame: Day 1 and Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125578


Locations
Layout table for location information
United States, Arizona
Research Site
Phoenix, Arizona, United States
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Publications of Results:
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02125578    
Other Study ID Numbers: 105HV102
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic