NCT00709540已完成1 期
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
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 <
- •Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).
排除标准
- •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.
- •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.
结局指标
主要结局
To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.
时间窗: specified timepoints in the protocol
次要结局
- 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)
研究者
研究点 (2)
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