NCT05216887

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Aducanumab	Administered as specified in the treatment arm.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2022-02-01
• Last updated: 2023-04-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study