Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aducanumab
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
aducanumab IV
aducanumab SC
Arm Description
Infusion of aducanumab over approximately 1 hour
Subcutaneously via injection
Outcomes
Primary Outcome Measures
PK parameter of SC dose of aducanumab: Absolute Bioavailability
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
PK parameter of aducanumab: Maximum observed concentration (Cmax)
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Secondary Outcome Measures
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with clinically significant vital sign abnormalities
Number of participants with clinically significant laboratory assessment abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
PK parameter of aducanumab: Terminal elimination half-life (t1/2)
PK parameter of aducanumab: Volume of distribution (Vd)
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02782975
Brief Title
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aducanumab IV
Arm Type
Experimental
Arm Description
Infusion of aducanumab over approximately 1 hour
Arm Title
aducanumab SC
Arm Type
Experimental
Arm Description
Subcutaneously via injection
Intervention Type
Drug
Intervention Name(s)
aducanumab
Other Intervention Name(s)
BIIB037
Primary Outcome Measure Information:
Title
PK parameter of SC dose of aducanumab: Absolute Bioavailability
Time Frame
13 weeks
Title
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame
13 weeks
Title
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame
13 weeks
Title
PK parameter of aducanumab: Maximum observed concentration (Cmax)
Time Frame
13 weeks
Title
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
13 weeks
Title
Number of participants with clinically significant vital sign abnormalities
Time Frame
13 weeks
Title
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame
13 weeks
Title
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame
13 weeks
Title
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
Title
PK parameter of aducanumab: Terminal elimination half-life (t1/2)
Time Frame
13 weeks
Title
PK parameter of aducanumab: Volume of distribution (Vd)
Time Frame
13 weeks
Title
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
12. IPD Sharing Statement
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Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
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