A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

NCT ID: NCT04924140

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-10-01

Brief Summary

The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers.

The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Aducanumab Intravenous

Participants will receive aducanumab as body weight-based dose, via IV infusion for approximately 1 hour on Day 1.

Group Type: EXPERIMENTAL

Aducanumab

Intervention Type: DRUG

Administered as specified in the treatment arm

Aducanumab Subcutaneous

Participants will receive aducanumab as fixed dose, via SC injection on Day 1.

Group Type: EXPERIMENTAL

Aducanumab

Intervention Type: DRUG

Administered as specified in the treatment arm

Interventions

Aducanumab

Administered as specified in the treatment arm

Intervention Type: DRUG

Other Intervention Names

BIIB037

Eligibility Criteria

Inclusion Criteria

• Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2), inclusive.
• Have a negative test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1.

Exclusion Criteria

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator.
• History of severe allergic, anaphylactic, or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, and diagnostic agents to be administered during the study.
• Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -1.
• Any immunization or vaccination given within 10 days prior to Day 1 and for 10 days after Day 1.
• Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
• Prior exposure to the study treatment or previous participation in this study or previous studies with aducanumab.
• Mini mental state examination (MMSE) score of <27 at screening.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Qps-Mra, Llc

South Miami, Florida, United States

Countries

United States

Other Identifiers

221HV103

Identifier Type: -

Identifier Source: org_study_id