Trial record 2 of 6 for:    BIIB037

Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02782975
First received: May 23, 2016
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.

Condition Intervention Phase
Alzheimer's Disease
Drug: aducanumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • PK parameter of SC dose of aducanumab: Absolute Bioavailability [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of aducanumab: Maximum observed concentration (Cmax) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically significant vital sign abnormalities [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of aducanumab: Terminal elimination half-life (t1/2) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of aducanumab: Volume of distribution (Vd) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • PK parameter of aducanumab: Apparent total body clearance (CL/F) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2016
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aducanumab IV
Infusion of aducanumab over approximately 1 hour
Drug: aducanumab
Other Name: BIIB037
Experimental: aducanumab SC
Subcutaneously via injection
Drug: aducanumab
Other Name: BIIB037

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • A minimum weight of 45 kg, inclusive, at Day -1.
  • All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
  • Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.

Key Exclusion Criteria:

  • Mini mental state examination (MMSE) score of <27 at Screening.
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
  • History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
  • History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
  • History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
  • Positive test result at Screening for hepatitis C virus antibody (HCVAb).
  • Positive test result at Screening for hepatitis B virus (defined as positive for both, hepatitis B surface antigen [HBsAg] AND hepatitis B core antibody [HBcAb]).
  • Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 90 days prior to Day -1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02782975

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
United States, Indiana
Research Site Recruiting
Evansville, Indiana, United States, 47710
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02782975     History of Changes
Other Study ID Numbers: 221HV102 
Study First Received: May 23, 2016
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2016