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NCT02257489 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of ACE-083 in Healthy Subjects

A Phase 1 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.

Completed
Registry status
Phase 1
Development phase
58
Enrollment target

NCT02257489: Completed Phase 1 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.

NCT02257489 is a Phase 1 study that has completed, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02257489, a Phase 1 study, has completed, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.

COMPLETED
Registry status
Phase 1
Development phase
58 participants
Enrollment target

Study 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.

Primary Outcome

Safety/tolerability assessment, following intramuscular administration, includes adverse events, injection site reactions, laboratory measurements, vital signs, etc.

Interventions

  • DRUG ACE-083

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2014-09
Est. Completion 2016-04
Phase Phase 1

What the finished NCT02257489 record still lists

NCT02257489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which ACE-083 is the first listed.

NCT02257489 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02257489 about?

NCT02257489 is a clinical study titled "Phase 1 Study of ACE-083 in Healthy Subjects". 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...

What is the current status of trial NCT02257489?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2014-09. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02257489?

The interventions under investigation include: ACE-083 (DRUG).

Who is sponsoring clinical trial NCT02257489?

This trial is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02257489's enrollment target sits among peer trials

58 895th of 2000 higher than 1,100 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02257489, the US trial registry maintained by the National Library of Medicine. NCT02257489 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.