drugset / Trial / NCT02782975

Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

NCT02782975

Phase 1 Completed 28 enrolled Biogen
RandomizedParallel-groupOpen-labelBasic science

Summary

The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.

Timeline

Start
2016-05
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Aducanumab Monoclonal antibody Intravenous

Indications