Study of ACE-536 in Healthy Postmenopausal Women

Acceleron Pharma

Status and phase: Completed; Phase 1

Conditions: Anemia

Treatments: Biological: ACE-536; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01432717

A536-02

Details and patient eligibility

About

The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.

Enrollment: 40 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Postmenopausal women
• Body Mass Index (BMI) of 20 - 32 kg/m2.

Key Exclusion Criteria:

• History of hypertension
• Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
• History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
• Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
• Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

ACE-536

Experimental group

Description:

Subjects assigned to 1 of 5 possible dosing groups.

Treatment:

Biological: ACE-536

Placebo

Placebo Comparator group

Treatment:

Other: Placebo