NCT00755638已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy, Postmenopausal Volunteers
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 48 人开始时间: 2008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
- 48
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
研究概览
简要总结
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is a postmenopausal woman, 45-75 years old (inclusive)
- •Subject has a body mass index (BMI) of > 18.5 to < 30
- •Subject must give written informed consent
排除标准
- •Subject has a history of malignancy. However, a subject with a history of excised or treated basal cell carcinoma, cervical carcinoma in-situ, or less than or equal to 2 squamous cell carcinomas is eligible to participate in this study.
- •Subject has a history of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
- •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.
- •Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
- •Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
- •Subject has a history of severe allergic or anaphylactic reactions.
- •Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
- •Subject had a fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
- •Subject has a positive Tuberculin skin test (Mantoux)
- •Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).
- •Subject has a recent or clinically significant history of drug or alcohol abuse, or tests positive in a urine screen for alcohol or drugs of abuse.
- •Subject consumed any alcohol within 48 hours prior to dosing.
- •Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
- •Subject has taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study.
结局指标
主要结局
To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
时间窗: specified timepoints in the protocol
次要结局
- To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031(specified timepoints in the protocol)
研究者
研究点 (1)
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