A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of DZD2269 Oral Tablet Following Single and Multiple Ascending Dose Administration to Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number and percentage of participants with adverse event (AE)
研究概览
简要总结
This is a research study in healthy participants. The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. This study will also investigate pharmacokinetics of DZD2269; renal excretion of DZD2269 will also be evaluated. The study will also measure biomarkers such as pCREB in the blood.
详细描述
A phase 1, randomized, double-blinded, placebo-controlled, study in healthy participants. This study includes two parts, Part A (single ascending dose escalation) and Part C (multiple ascending dose escalation).
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, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DZD2269
This study includes two parts. In Part A, a single dose of DZD2269 at different dose levels will be given. In Part C, DZD2269 at selected dose levels will be given twice daily for 7 days.
干预措施: DZD2269 (Drug)
Placebo
In Part A, a single oral dose of placebo will be given. In Part C, placebo will be given twice daily for 7 days.
干预措施: placebo (Drug)
结局指标
主要结局
Number and percentage of participants with adverse event (AE)
时间窗: From first dose until 5 days after the last dose (Up to 6 days for Part A; 12 days for Part C)
"To assess the safety and tolerability of DZD2269 versus placebo following oral administration"
Number and percentage of participants with serious adverse event (SAE)
时间窗: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined abnormal laboratory values
时间窗: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined ECG abnormalities
时间窗: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined abnormal vital signs
时间窗: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
次要结局
- Drug concentrations of DZD2269 in plasma(After the first dose, 6 days for Part A; 7 days for Part C)
- Maximum plasma concentration (Cmax) of DZD2269(After the first dose, 6 days for Part A; 7 days for Part C)
- Area under the plasma concentration-time curve (AUC) of DZD2269(After the first dose, 6 days for Part A; 7days for Part C)