Study of ACE-536 in Healthy Postmenopausal Women

Sponsor

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)

Overall Status

Completed

CT.gov ID

NCT01432717

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Biological: ACE-536 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACE-536 Subjects assigned to 1 of 5 possible dosing groups.	Biological: ACE-536 Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
Placebo Comparator: Placebo	Other: Placebo Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.

Arm

Intervention/Treatment

Experimental: ACE-536

Subjects assigned to 1 of 5 possible dosing groups.

Biological: ACE-536

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

Placebo Comparator: Placebo

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events as a measure of safety and tolerability. [22 weeks]

Secondary Outcome Measures

ACE-536 serum concentration after single and multiple ascending doses. [22 weeks]
Hemoglobin levels after single and multiple ascending doses. [22 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acceleron Investigative Site	Tempe	Arizona	United States

Sponsors and Collaborators

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

ClinicalTrials.gov Identifier:

NCT01432717

Other Study ID Numbers:

A536-02

First Posted:

Sep 13, 2011

Last Update Posted:

Nov 7, 2012

Last Verified:

Nov 1, 2012

Additional relevant MeSH terms:

Luspatercept

Study Results

No Results Posted as of Nov 7, 2012