NCT04924140

A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) Compared to a Single, Weight-Based Intravenous Dose in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Aducanumab	Administered as specified in the treatment arm

Timeline

• Start date: 2021-06-30
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2021-06-11
• Last updated: 2023-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study