drugset / Trial / NCT02257489
Phase 1 Study of ACE-083 in Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |