Muscle Loss
Conditions
Brief summary
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
Interventions
BIOLOGICALACE-031
single subcutaneous dose of ACE-031
Sponsors
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Subject is a postmenopausal woman, 45-75 years old (inclusive) 2. Subject has a body mass index (BMI) of \> 18.5 to \< 30 3. Subject must give written informed consent Key
Exclusion criteria
1. 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. 2. 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. 3. 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. 4. Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia). 5. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening. 6. Subject has a history of severe allergic or anaphylactic reactions. 7. Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures). 8. Subject had a fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing. 9. Subject has a positive Tuberculin skin test (Mantoux) 10. Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV). 11. 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. 12. Subject consumed any alcohol within 48 hours prior to dosing. 13. Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration. 14. 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031 | specified timepoints in the protocol |
Countries
Canada
Outcome results
None listed