A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

NCT04924140 | Completed Phase 1 FDA Drug

• 1 other identifier: 221HV103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab

  Up to Day 85

• Maximum Observed Concentration (Cmax) of Aducanumab

  Up to Day 85

Secondary Outcomes (9)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in Vital Signs

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)

  Up to Day 85

• Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments

  Up to Day 85

• Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab

  Up to Day 85

Study Arms (2)

Aducanumab Intravenous

EXPERIMENTAL

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

Drug: Aducanumab

Aducanumab Subcutaneous

EXPERIMENTAL

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

Drug: Aducanumab

Interventions

Aducanumab DRUG

Administered as specified in the treatment arm

Also known as: BIIB037

Aducanumab Intravenous; Aducanumab Subcutaneous

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Eisai Co., Ltd.: collaborator

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

MeSH Terms

Interventions

aducanumab

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: June 30, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)