A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

Muscular Atrophy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952887
• Other study ID #: A031-02
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2009
• Last updated: March 22, 2011
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Acceleron Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postmenopausal

• Body mass index (BMI) of = 18.5 to < 32.

Exclusion Criteria:

• History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or = 2 squamous cell carcinomas

• History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.

• History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.

• Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).

• Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1.

• Donation or significant loss of blood within 2 months prior to Day 1.

• Hormone replacement therapy within 3 months prior to Day 1.

• Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1.

• Systemic glucocorticoid therapy within 6 months prior to Day 1.

• Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1.

• Previous treatment with ACE-031.

Study Design

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

Related Conditions & MeSH terms

• Muscular Atrophy

Intervention

Biological:
• ACE-031
Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.
• Placebo
Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.

Locations

Country	Name	City	State
Canada	Acceleron Investigative Site	Montreal
Canada	Acceleron Investigative Site	Quebec City

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 multiple, escalating doses of ACE-031 in healthy postmenopausal women		6.5 months	Yes
Secondary	To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031		6.5 months	No