- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782975
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
January 12, 2017 updated by: Biogen
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Evansville, Indiana, United States, 47710
- Research Site
-
-
Texas
-
Dallas, Texas, United States, 75247
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aducanumab IV
Infusion of aducanumab over approximately 1 hour
|
Other Names:
|
Experimental: aducanumab SC
Subcutaneously via injection
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK parameter of SC dose of aducanumab: Absolute Bioavailability
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of aducanumab: Maximum observed concentration (Cmax)
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Time Frame: 13 weeks
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 13 weeks
|
13 weeks
|
Number of participants with clinically significant vital sign abnormalities
Time Frame: 13 weeks
|
13 weeks
|
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame: 13 weeks
|
13 weeks
|
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame: 13 weeks
|
13 weeks
|
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
|
13 weeks
|
PK parameter of aducanumab: Terminal elimination half-life (t1/2)
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of aducanumab: Volume of distribution (Vd)
Time Frame: 13 weeks
|
13 weeks
|
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
May 23, 2016
First Submitted That Met QC Criteria
May 23, 2016
First Posted (Estimate)
May 26, 2016
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 221HV102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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