A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 144
- 主要终点
- Pharmacokinetics of MV088/Prolia in plasma: Cmax
研究概览
简要总结
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
详细描述
This is a phase I, double center, randomized, double-blind, single dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of MV088 and Prolia® in healthy volunteers. The secondary objectives is to assess the similarity of clinical safety and immunogenicity of MV088 and Prolia® in healthy volunteers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 years or ≤65 years, male(including the boundary value).
- •The body weight is within the range of 50~70kg (including the boundary value) and the body mass index（BMI） is within the range of 19.0~26.0kg/m2 (including the boundary value).
- •Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements.
- •The volunteers are able to communicate well with the researchers, understand and comply with the requirements of the study, and are expected to participate in all follow-up visits (no long-term plans to leave the study site).
排除标准
- •Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration.
- •Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
- •The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed.
- •Occurred or suffering hypocalcemia.
- •Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.
研究组 & 干预措施
MV088
MV088 injection (60mg) by subcutaneous injection once on the first day
干预措施: MV088 injection (Drug)
Prolia®
Prolia® injection (60mg) by subcutaneous injection once on the first day
干预措施: Prolia® injection (Drug)
结局指标
主要结局
Pharmacokinetics of MV088/Prolia in plasma: Cmax
时间窗: 126 days
To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
时间窗: 126 days
To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer
次要结局
- Pharmacokinetics of MV088/Prolia in plasma: Vz/F(126 days)
- Pharmacokinetics of MV088/Prolia in plasma: Tmax(126 days)
- Pharmacokinetics of MV088/Prolia in plasma: AUC0-t(126 days)
- Pharmacokinetics of MV088/Prolia in plasma: t1/2(126 days)
- Safety evaluation of MV088/Prolia(126 days)
- Pharmacokinetics of MV088/Prolia in plasma: CLz/F(126 days)
- Pharmacokinetics of MV088/Prolia in plasma: λz(126 days)
- Immunogenicity evaluation of MV088/Prolia(126 days)