A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women

NCT ID: NCT00709540

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-11-30

Brief Summary

This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

single

10 subjects (8 active and 2 placebo)

Group Type: EXPERIMENTAL

ACE-011 or placebo

Intervention Type: BIOLOGICAL

multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)

Interventions

ACE-011 or placebo

multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subject is a postmenopausal woman, 45-85 years old (inclusive).

2. Subject has had 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels >40 IU/L OR is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.

3. Subject is taking at least 500 mg of calcium supplement and 400 IU of vitamin D daily and has been following this regimen for at least 4 weeks prior to the first dose of study drug administration.

4. Subject has a body mass index (BMI) of ≥ 18.5 to < 30.

5. Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).

Exclusion Criteria

1. Subject has a history of clinically significant major disease (as determined by the Investigator).

2. Subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia.

3. Subject has had a long bone fracture within the past 6 months prior to enrollment, or an osteoporosis-related fracture within the previous 2 years.

4. Subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening.

5. Subject has a history of severe allergic or anaphylactic reactions.

6. Subject had major surgery within the previous 3 months.

7. Subject has a history of drug or alcohol abuse, or tests positive in a drug and alcohol screen at screening or on Day 1 prior to dosing.

8. Subject consumed any alcohol within 72 hours prior to dosing.

9. Subject gave a blood donation (one unit or more) within 1 month prior to dosing, or plans to give a blood donation during the course of the study.

10. Subject has taken any of the following bone active medications:

• Teriparatide at any time in their lifetime.
• Fluoride therapy for more than 3 months during the previous 2 years.
• Estrogen, androgen, anabolic steroids, corticosteroids (excluding inhaled, topical or local injections for joint pain), calcitonin, or other bone active drugs (e.g. selective estrogen receptor modulators) within the 4 months prior to screening.

Bisphosphonates:

• If treated for more than 6 months at any time in their lifetime.
• If treated for 3 to 6 months within 2 years of screening.
• If treated for less than 3 months within 6 months of screening.

11. Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Ababa, MD

Role: PRINCIPAL_INVESTIGATOR

West Coast Clinical Trials

Locations

West Coast Clinical Trials

Cypress, California, United States

Countries

United States

Other Identifiers

A011-02

Identifier Type: -

Identifier Source: org_study_id