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

NCT ID: NCT02782975

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

aducanumab IV

Infusion of aducanumab over approximately 1 hour

Group Type: EXPERIMENTAL

aducanumab

Intervention Type: DRUG

aducanumab SC

Subcutaneously via injection

Group Type: EXPERIMENTAL

aducanumab

Intervention Type: DRUG

Interventions

aducanumab

Intervention Type: DRUG

Other Intervention Names

BIIB037

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Evansville, Indiana, United States

Research Site

Dallas, Texas, United States

Countries

United States

Other Identifiers

221HV102

Identifier Type: -

Identifier Source: org_study_id