A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
研究概览
简要总结
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected.
This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.
There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Part A: Overtly healthy PMP females
- •Part B: PMP women who are currently taking oral bisphosphonates
- •Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
排除标准
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Have known allergies to blosozumab, its constituents, or related compounds
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
研究组 & 干预措施
Blosozumab
Weekly SC injections of blosozumab for 6 weeks.
干预措施: Blosozumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
时间窗: Predose and daily up through 7 days postdose
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
PK: Area Under the Concentration Curve of Blosozumab
时间窗: Predose and daily up through 7 days postdose
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
次要结局
未报告次要终点