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

A Randomized, Open-Label, Parallel-Arm Study to Assess the Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Biological: Aducanumab

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
  • Florida
    • Miami, Florida, United States, 33143
      • QPS-MRA
  • Missouri
    • Springfield, Missouri, United States, 65802
      • QPS Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key 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

Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aducanumab IV; Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1.	Biological: Aducanumab; Administered as specified in the treatment arm.; Other Names: BIIB037; Aduhelm
Experimental: Aducanumab SC; Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15.	Biological: Aducanumab; Administered as specified in the treatment arm.; Other Names: BIIB037; Aduhelm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab	Predose and at multiple time points post-dose up to Day 99

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.	Up to Day 99
Number of Participants with Clinically Significant Abnormal Vital Sign Values		Up to Day 99
Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values		Day 1 and Day 99
Number of Participants with Clinically Significant Abnormal Laboratory Values		Up to Day 99
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab		Predose and at multiple time points post-dose up to Day 28
Maximum Observed Concentration (Cmax) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC		Predose and at multiple time points post-dose up to Day 99
Elimination Half-Life (t1/2) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab		Predose and at multiple time points post-dose up to Day 99

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 221HV104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No