Study of ACE-536 in Healthy Postmenopausal Women

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01432717

Enrollment

Registered

2011-09-13

Start date

2011-09-30

Completion date

2012-10-31

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

BIOLOGICALACE-536

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026