CompletedPhase 1

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

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

Lead sponsor

Biogen

Asset

Aducanumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoints

•PK parameter of SC dose of aducanumab•PK parameter of IV dose of aducanumab•PK parameter of aducanumab

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID221HV102

NCT IDNCT02782975

Timeline

Milestones

Study start2016-05 (month precision)

Study first posted2016-05-26estimated

Primary completion2016-11actual (month precision)

Study completion2016-11actual (month precision)

Last update posted2017-01-13estimated

Assets

Drug assets

Aducanumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion 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

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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

PK parameter of aducanumab: Maximum observed concentration (Cmax)

Time frame:13 weeks

concentration, descriptive

Primary/protocol endpoint

PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)

Time frame:13 weeks

time to event, event

Secondary/protocol endpoint

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:13 weeks

event count, event

Secondary/protocol endpoint

Number of participants with clinically significant vital sign abnormalities

Time frame:13 weeks

event count, event

Secondary/protocol endpoint

PK parameter of aducanumab: Terminal elimination half-life (t1/2)

Time frame:13 weeks

concentration, descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

PK parameter of SC dose of aducanumab: Absolute Bioavailability

Time frame:13 weeks

descriptive

Primary/protocol endpoint/low confidence

PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)

Time frame:13 weeks

concentration, descriptive

Primary/protocol endpoint/low confidence

PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)

Time frame:13 weeks

concentration, descriptive