A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    sotatercept ...
  • Study Participants

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.
Study Started
Jan 31
Primary Completion
Nov 30
Study Completion
Nov 30
Last Update
Jul 21

Biological ACE-011 or placebo

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

single Experimental

10 subjects (8 active and 2 placebo)


Inclusion Criteria:

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).

Exclusion Criteria:

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.


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.
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.
No Results Posted