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

NCT00709540 | Completed Phase 1 DMC

• 1 other identifier: A011-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.

  specified timepoints in the protocol

Secondary Outcomes (1)

• 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

Study Arms (1)

single

EXPERIMENTAL

10 subjects (8 active and 2 placebo)

Biological: ACE-011 or placebo

Interventions

ACE-011 or placebo BIOLOGICAL

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

single

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a postmenopausal woman, 45-85 years old (inclusive).
• 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.
• 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.
• Subject has a body mass index (BMI) of ≥ 18.5 to \< 30.
• Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).

You may not qualify if:

• Subject has a history of clinically significant major disease (as determined by the Investigator).
• Subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia.
• 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.
• Subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening.
• Subject has a history of severe allergic or anaphylactic reactions.
• Subject had major surgery within the previous 3 months.
• 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.
• Subject consumed any alcohol within 72 hours prior to dosing.
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michelle Ababa, MD

  West Coast Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)