A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women

Conditions
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Muscular Atrophy

Intervention / Treatment
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* Biological: ACE-031
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Body mass index (BMI) of ≥ 18.5 to < 32. Exclusion Criteria: History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening. Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures). Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1. Donation or significant loss of blood within 2 months prior to Day 1. Hormone replacement therapy within 3 months prior to Day 1. Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1. Systemic glucocorticoid therapy within 6 months prior to Day 1. Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1. Previous treatment with ACE-031.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE-031<br>8 dosing groups | Biological: ACE-031<br>* 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.<br>* Other names: ActRIIB-IgG1;|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women |  | 6.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031 |  | 6.5 months |