A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers

NCT ID: NCT05216887

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-07-27

Brief Summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.

Conditions

Healthy Volunteer

Study Design

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

Study Groups

Aducanumab IV

Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1.

Group Type: ACTIVE_COMPARATOR

Aducanumab

Intervention Type: BIOLOGICAL

Administered as specified in the treatment arm.

Aducanumab SC

Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15.

Group Type: EXPERIMENTAL

Aducanumab

Intervention Type: BIOLOGICAL

Administered as specified in the treatment arm.

Interventions

Aducanumab

Administered as specified in the treatment arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

BIIB037; Aduhelm

Eligibility Criteria

Inclusion Criteria

• Have a body mass index between 18 and 30 kilograms per meter square (kg/m^2), inclusive
• Japanese participant has both biological parents and all 4 grandparents of Japanese descent
• Have a negative polymerase chain reaction 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, any diagnostic agents to be administered during the study
• History of, or positive test result at Screening for, human immunodeficiency virus
• History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
• Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degrees Celsius [°C]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
• 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
• Any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment
• Mini mental state examination score of < 27 at Screening

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 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

Anaheim Clinical Trials

Anaheim, California, United States

QPS-MRA

Miami, Florida, United States

QPS Missouri

Springfield, Missouri, United States

Countries

United States

Other Identifiers

221HV104

Identifier Type: -

Identifier Source: org_study_id