Trial · Interventional
CompletedPhase 1Registry dataA Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 48 participants (actual)
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Canada
- Start
- Sept 2008
- Primary completion
- Jul 2009
- Completion
- Jul 2009
- First posted
- 19 Sept 2008 (estimated)
- Last update posted
- 14 Jul 2009 (estimated)
- Conditions
- Muscle Loss
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
NCT00755638Sept 2008 to Jul 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
Interventions
- ACE-031Biological
Arms1
Experimental
single
8 subjects (6 active and 2 placebo)
Primary outcomes1
Outcomes the sponsor listed as primary.
To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
Time frame · specified timepoints in the protocol
Secondary outcomes(1)
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031
Time frame · specified timepoints in the protocol
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 45 Years up to 75 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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