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

NCT05216887 | Completed Phase 1 FDA Drug

• 1 other identifier: 221HV104
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  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

Study Arms (2)

Aducanumab IV

ACTIVE COMPARATOR

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

Biological: Aducanumab

Aducanumab SC

EXPERIMENTAL

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

Biological: Aducanumab

Interventions

Aducanumab BIOLOGICAL

Administered as specified in the treatment arm.

Also known as: BIIB037, Aduhelm

Aducanumab IV; Aducanumab SC

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

QPS-MRA

Miami, Florida, 33143, United States

Location

QPS Missouri

Springfield, Missouri, 65802, 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: January 19, 2022
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)