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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Biological: ACE-011 or placebo

• Registration Number: NCT00709540
• Lead Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single	ACE-011 or placebo	10 subjects (8 active and 2 placebo)

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.	specified timepoints in the protocol

Secondary Outcome Measures

Name	Time	Method
To estimate the pharmacokinetic (PK) parameters of multiple, escalating doses of ACE-011 administered subcutaneously and to determine the effect of ACE-011 on bone mineral density (BMD) and biochemical markers of bone formation and resorption.	at specified timepoints in the protocol

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States