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Completed

NCT Number: NCT01432717

Study of ACE-536 in Healthy Postmenopausal Women

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Acceleron Investigative Site

Tempe, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACE-536

Biological

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

Placebo

Other

Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.

Primary outcomes

  1. Number of participants with Adverse Events as a measure of safety and tolerability.

    Time frame: 22 weeks

Secondary outcomes

  1. ACE-536 serum concentration after single and multiple ascending doses.

    Time frame: 22 weeks

  2. Hemoglobin levels after single and multiple ascending doses.

    Time frame: 22 weeks

Sponsors and collaborators

Lead sponsor

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2011
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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