Study of ACE-536 in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Anemia
• Interventions: Other: Placebo; Biological: ACE-536

• Registration Number: NCT01432717
• Lead Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ACE-536	ACE-536	Subjects assigned to 1 of 5 possible dosing groups.

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events as a measure of safety and tolerability.	22 weeks

Secondary Outcome Measures

Name	Time	Method
ACE-536 serum concentration after single and multiple ascending doses.	22 weeks
Hemoglobin levels after single and multiple ascending doses.	22 weeks

Trial Locations

Locations (1)

Acceleron Investigative Site; 🇺🇸 Tempe, Arizona, United States