A Phase 1, Open-Label, Randomized-Sequence, Single-Crossover, Bridging Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Two ND-L02-s0201 Formulations, Frozen Versus Lyophilized, Administered by Intravenous Infusion to Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Time to maximum plasma concentration (Tmax)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health, as determined by the Investigator
- •Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug
- •Subject has serum calcium and parathyroid hormone (intact) within the limits of the normal range of the laboratory
排除标准
- •Subject has a disease or condition (medical or surgical) which, in the opinion of the Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201 solution, or that may place the subject at increased risk
- •Subject has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma
- •Subject has abnormal laboratory values considered to be clinically significant by the Investigator
- •Other protocol inclusion/exclusion criteria may apply
研究组 & 干预措施
Module A
Lyophilized Formulation
干预措施: ND-L02-s0201 (Drug)
Module B
Frozen Formulation
干预措施: ND-L02-s0201 (Drug)
结局指标
主要结局
Time to maximum plasma concentration (Tmax)
时间窗: Up to 28 days
Apparent first-order terminal elimination rate constant (Kel)
时间窗: Up to 28 days
Volume of distribution during the elimination phase after IV administration (Vz)
时间窗: Up to 28 days
Maximum plasma concentration (Cmax)
时间窗: Up to 28 days
Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
时间窗: Up to 28 days
Apparent volume of distribution at steady-state (Vss)
时间窗: Up to 28 days
Apparent first-order terminal elimination half-life (T1/2)
时间窗: Up to 28 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
时间窗: Up to 28 days
Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
时间窗: Up to 28 days
Total plasma clearance of drug after IV administration (CL/F)
时间窗: Up to 28 days
次要结局
- Incidence of adverse events (AEs)(Up to 28 days)
- Incidence of discontinuations of study drug due to toxicity(Up to 28 days)
- Incidence of serious adverse events (SAEs)(Up to 28 days)