drugset / Trial / NCT02257489

Phase 1 Study of ACE-083 in Healthy Subjects

NCT02257489 ↗

Phase 1 Completed 58 enrolled Acceleron Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and tolerability of single and multiple doses of ACE-083 as a local injection into selected skeletal muscles of healthy subjects. The study will also determine the amount of ACE-083 that reaches the systemic circulation following local administration. Additionally, the study will assess whether local administration into skeletal muscle results in an increase in the size and/or strength of the injected muscle.

Timeline

Start
2014-09
Primary completion
2016-03
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject EFMITERMANT ALFA Protein / enzyme biologic 50 mg —
Subject EFMITERMANT ALFA Protein / enzyme biologic 100 mg —
Subject EFMITERMANT ALFA Protein / enzyme biologic 150 mg —
Subject EFMITERMANT ALFA Protein / enzyme biologic 200 mg —