Study of ACE-536 in Healthy Postmenopausal Women

Anemia Clinical Trial

Official title:

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432717
• Other study ID #: A536-02
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2011
• Last updated: November 5, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Acceleron Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Biological:
• ACE-536
Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.

Other:
• Placebo
Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.

Locations

Country	Name	City	State
United States	Acceleron Investigative Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Acceleron Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a measure of safety and tolerability.		22 weeks	Yes
Secondary	ACE-536 serum concentration after single and multiple ascending doses.		22 weeks	No
Secondary	Hemoglobin levels after single and multiple ascending doses.		22 weeks	No