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The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE-031 | Experimental | 8 dosing groups |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE-031 | Biological | Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women | 6.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031 | 6.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Larouche, MD | Anapharm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acceleron Investigative Site | Montreal | Canada | ||||
| Acceleron Investigative Site |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| C579679 | ACVR2B protein, human |
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|
| Placebo | Biological | Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months. |
|
| Québec |
| Canada |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |