NCT00952887已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-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 70 人开始时间: 2009年8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
- 70
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
研究概览
简要总结
The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal
- •Body mass index (BMI) of ≥ 18.5 to < 32.
排除标准
- •History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas
- •History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
- •History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
- •Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).
- •Fever or symptomatic viral or bacterial infection within 7 days prior to Day
- •Donation or significant loss of blood within 2 months prior to Day
- •Hormone replacement therapy within 3 months prior to Day
- •Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day
- •Systemic glucocorticoid therapy within 6 months prior to Day
- •Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day
- •Previous treatment with ACE-031.
结局指标
主要结局
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
时间窗: 6.5 months
次要结局
- To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031(6.5 months)
研究者
研究点 (2)
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