NCT01432717已完成1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年9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
- 1
- 主要终点
- Number of participants with Adverse Events as a measure of safety and tolerability.
研究概览
简要总结
The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.
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 women
- •Body Mass Index (BMI) of 20 - 32 kg/m
排除标准
- •History of hypertension
- •Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
- •History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
- •Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
- •Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer
结局指标
主要结局
Number of participants with Adverse Events as a measure of safety and tolerability.
时间窗: 22 weeks
次要结局
- ACE-536 serum concentration after single and multiple ascending doses.(22 weeks)
- Hemoglobin levels after single and multiple ascending doses.(22 weeks)
研究者
研究点 (1)
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