A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring
研究概览
简要总结
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
详细描述
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.
Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.
Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- •Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
排除标准
- •Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- •History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
研究组 & 干预措施
Placebo
Placebo tablets
干预措施: Placebo (Drug)
Q203
Q203 tablets
干预措施: Q203 (Drug)
结局指标
主要结局
Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring
时间窗: 16 days post dose
次要结局
- Pharmacokinetic analysis: Area under the curve(16 days post dose)
- Pharmacokinetic analysis: Maximum observed plasma drug concentration(16 days post dose)
- Pharmacokinetic analysis: Time of maximum observed concentration(16 days post dose)