At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
ACE-083drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Local Muscle Injections of ACE-083 in Healthy Postmenopausal Women
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA·interventional·Posted Oct 6, 2014·Updated Sep 23, 2022
In Brief
A Phase 1 clinical trial evaluating ACE-083 for Musculoskeletal Diseases. Completed, enrolled 58 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMusculoskeletal Diseases
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedOct 6, 2014
Enrollment StartSep 1, 2014
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.7 years ago
Interventions
ACE-083drug
recombinant fusion protein