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

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

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

Study Overview

• Status: Completed
• Conditions: Muscle Loss
• Intervention / Treatment: Biological: ACE-031

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Acceleron Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2009
• Last Update Submitted That Met QC Criteria: July 10, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: A031-01