drugset
drugset / Trial / NCT04924140

A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

NCT04924140 ↗

Phase 1 Completed 30 enrolled Biogen Eisai Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-06-30
Primary completion
2021-10-01
Completion
2021-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aducanumab Monoclonal antibody — Intravenous

Indications

No indication recorded.