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Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02269930
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:

The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: peginterferon beta-1a Drug: Rebif Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29
Drug: peginterferon beta-1a
Administered as subcutaneous injection
Other Names:
  • BIIB017
  • Plegridy

Drug: Rebif
Administered as subcutaneous injection

Experimental: Group 2
Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41
Drug: peginterferon beta-1a
Administered as subcutaneous injection
Other Names:
  • BIIB017
  • Plegridy

Drug: Rebif
Administered as subcutaneous injection




Primary Outcome Measures :
  1. Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of BIIB017 and Rebif [ Time Frame: 2 weeks ]
  2. Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to 4 weeks following treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1

Key Exclusion Criteria:

  • History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb])
  • History of premalignant and malignant disease including solid tumors and hematologic malignancies
  • Known allergy to any interferon or any component of BIIB017
  • Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer

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): NCT02269930


Locations
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United States, Indiana
Research Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02269930    
Other Study ID Numbers: 105HV105
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases