A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

Study Overview
=================
Brief Summary
-----------------
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers

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

Conditions
-----------------
Muscle Loss

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject is a postmenopausal woman, 45-75 years old (inclusive) Subject has a body mass index (BMI) of > 18.5 to < 30 Subject must give written informed consent Key Exclusion Criteria: Subject has a history of malignancy. However, a subject with a history of excised or treated basal cell carcinoma, cervical carcinoma in-situ, or less than or equal to 2 squamous cell carcinomas is eligible to participate in this study. Subject has a history of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry. Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia). Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening. Subject has a history of severe allergic or anaphylactic reactions. Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures). Subject had a fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing. Subject has a positive Tuberculin skin test (Mantoux) Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV). Subject has a recent or clinically significant history of drug or alcohol abuse, or tests positive in a urine screen for alcohol or drugs of abuse. Subject consumed any alcohol within 48 hours prior to dosing. Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration. Subject has taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study.

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single<br>8 subjects (6 active and 2 placebo) | Biological: ACE-031<br>* single subcutaneous dose of ACE-031<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers |  | specified timepoints in the protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031 |  | specified timepoints in the protocol |