A Randomized, Double-blind, Two-arm, Single-dose, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and EU-approved Xgeva® in Normal Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- AUC0-t, area under the curve from 0 h to the last measurable concentration calculated by the linear-log trapezoidal method
研究概览
简要总结
This study is aimed todetermine the PK and PD comparability, safety, and tolerability of Bmab 1000versus Xgeva (denosumab) in healthy, adult male volunteers for demonstratingbiosimilarity in accordance with the Japanese Pharmaceuticals and MedicalDevices Agency (PMDA), United States Food and Drug Administration (FDA),European Medicines Agency (EMA), and New Drugs and Clinical Trials Rules, 2019of the CDSCO (Central Drugs Standard Control Organization) guidance documents.
Bmab 1000 is beingdeveloped as a proposed biosimilar to Xgeva. This study is aimed to determinethe PK and PD comparability, safety, and tolerability of Bmab 1000 versus Xgeva(denosumab) in healthy, adult male volunteers for demonstrating biosimilarityin accordance with the PMDA, US FDA, EMA, and CDSCO guidance documents. Thiswill be a single-dose, bioequivalence study following subcutaneous injection innormal healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
AUC0-t, area under the curve from 0 h to the last measurable concentration calculated by the linear-log trapezoidal method
时间窗: 0-253 day
Cmax, maximum observed denosumab concentration
时间窗: 0-253 day
• AUC0-∞, area under the curve from 0 h to infinity
时间窗: 0-253 day
次要结局
- t1/2, half-life(0-253 days)
- kel, elimination rate constan(0-253 days)
- Vd/F, apparent volume of distribution(0-253 days)
- Tmax, time to reach Cmax(0-253 days)
- CL/F, apparent clearance.(0-253 days)