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

NCT00952887 | Completed Phase 1 DMC

• 1 other identifier: A031-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women

  6.5 months

Secondary Outcomes (1)

• To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031

  6.5 months

Study Arms (2)

ACE-031

EXPERIMENTAL

8 dosing groups

Biological: ACE-031

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

ACE-031 BIOLOGICAL

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.

Also known as: ActRIIB-IgG1

ACE-031

Placebo BIOLOGICAL

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.

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Acceleron Investigative Site

Montreal, Canada

Location

Acceleron Investigative Site

Québec, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

ACVR2B protein, human

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Richard Larouche, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

CA (2)