A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
Study Details
Study Description
Brief Summary
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: single 8 subjects (6 active and 2 placebo) |
Biological: ACE-031
single subcutaneous dose of ACE-031
|
Outcome Measures
Primary Outcome Measures
- 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
- To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031 [specified timepoints in the protocol]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Subject is a postmenopausal woman, 45-75 years old (inclusive)
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Subject has a body mass index (BMI) of > 18.5 to < 30
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Subject must give written informed consent
Key Exclusion Criteria:
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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.
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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.
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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.
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Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
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Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
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Subject has a history of severe allergic or anaphylactic reactions.
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Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
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Subject had a fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
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Subject has a positive Tuberculin skin test (Mantoux)
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Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).
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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.
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Subject consumed any alcohol within 48 hours prior to dosing.
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Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acceleron Investigative Site | Montreal | Quebec | Canada |
Sponsors and Collaborators
- Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A031-01