A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 154
- 试验地点
- 4
- 主要终点
- AUClast
研究概览
简要总结
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
详细描述
This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A Randomized, Double-blind
入排标准
- 年龄范围
- 28 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject, between the ages of 28 and 55 years, both inclusive
- •Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- •Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)
排除标准
- •Subject was a female.
- •Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).
- •Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.
- •Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.
- •Subjects with known risk factors for hypocalcaemia
- •Subjects with known intolerance to calcium or vitamin D supplements
- •Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis
- •Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.
- •Subjects have or had any therapy that might significantly affect bone metabolism
结局指标
主要结局
AUClast
时间窗: up to Day 253
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Cmax
时间窗: up to Day 253
maximum serum concentration (Cmax)
AUCinf
时间窗: up to Day 253
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
次要结局
未报告次要终点