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

Muscle Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755638
• Other study ID #: A031-01
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2008
• Last updated: July 10, 2009
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Acceleron Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Loss

Intervention

Biological:
• ACE-031
single subcutaneous dose of ACE-031

Locations

Country	Name	City	State
Canada	Acceleron Investigative Site	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Acceleron Pharma, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers		specified timepoints in the protocol	Yes
Secondary	To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031		specified timepoints in the protocol	No