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

Acceleron Pharma

Status and phase

Completed

Phase 1

Conditions

Muscular Atrophy

Treatments

Biological: ACE-031

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952887

A031-02

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.