A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause.
This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Part A: Overtly healthy postmenopausal (PMP) females
- •Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis
- •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
- •Have known allergies to blosozumab, its constituents, or related compounds
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
- •History of breast carcinoma
- •Fracture of a long bone within 1 year of screening
- •Have used teriparatide within 3 years prior to screening
研究组 & 干预措施
Placebo
Part A. Placebo administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
干预措施: Placebo (Other)
Blosozumab Formulation B
Part A. Blosozumab administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
干预措施: Blosozumab (Biological)
Blosozumab Formulation A
Part A. Blosozumab administered as 2 subcutaneous (SC) injections in week 1 followed by once weekly (QW) injections SC in weeks 2 to 6, followed by six week follow-up period.
干预措施: Blosozumab (Biological)
Blosozumab (Part B)
Part B. Blosozumab formulation determined by Part A administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
干预措施: Blosozumab (Biological)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 85
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
次要结局
- Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B(Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose)
- Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B(Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose)
- Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B(Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose)