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

NCT ID: NCT00755638

Last Updated: 2009-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

Brief Summary

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

Conditions

Muscle Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

single

8 subjects (6 active and 2 placebo)

Group Type: EXPERIMENTAL

ACE-031

Intervention Type: BIOLOGICAL

single subcutaneous dose of ACE-031

Interventions

ACE-031

single subcutaneous dose of ACE-031

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Acceleron Pharma Inc.

Locations

Acceleron Investigative Site

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

A031-01

Identifier Type: -

Identifier Source: org_study_id