A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00952887

Enrollment

Registered

2009-08-06

Start date

2009-08-31

Completion date

2011-02-28

Last updated

2011-03-23

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

Conditions

Muscular Atrophy

Brief summary

The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.

Interventions

BIOLOGICALACE-031

Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.

BIOLOGICALPlacebo

Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.

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

* Postmenopausal * Body mass index (BMI) of ≥ 18.5 to \< 32.

Exclusion criteria

* History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas * History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. * History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening. * Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures). * Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1. * Donation or significant loss of blood within 2 months prior to Day 1. * Hormone replacement therapy within 3 months prior to Day 1. * Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1. * Systemic glucocorticoid therapy within 6 months prior to Day 1. * Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1. * Previous treatment with ACE-031.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women	6.5 months

Secondary

Measure	Time frame
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031	6.5 months

Countries

Canada

Outcome results

None listed

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