NCT07757152招募中1 期
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China: Randomized, Double-blind, Placebo-controlled, Single/Multiple Oral Dose Escalation for Safety Tolerability, Pharmacokinetics, Preliminary Pharmacodynamics, and Food Effect
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of ZL-65 tablets.Exploring the impact of food intake on the PK of orally administered ZL-65 tablets in healthy adult trial participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participants for the Chinese trial, gender-neutral, aged 18 to 45;
- •Male trial participants weighing >= 50.0 kg, female trial participants weighing >=45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m^2;
- •Those who can understand the informed consent form, voluntarily participate in the experiment, and sign the informed consent form.
排除标准
- •Individuals with allergies or a history of clinically significant food, drug allergies, or other allergic diseases as determined by researchers; Or those who are known to be allergic to NLRP3 inhibitors or to the excipients contained in the test drug;
- •.Individuals with any serious illness or medical history of cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental illness, etc;
- •Pregnant or lactating women or women of childbearing age who have had unprotected sexual intercourse with their partners within 14 days prior to screening; Or those with positive results in blood pregnancy test;
- •Within 48 hours prior to administration, consuming any food or beverage containing caffeine, or fruits or vegetables containing grapefruit juice, soybeans, flavonoids that may affect metabolic enzymes, or consuming foods or beverages containing alcohol。
研究组 & 干预措施
ZL65 Tables
Experimental
ZL65
干预措施: This group of participants take ZL-65 tablet (Drug)
ZL65-Placebo Tables
Placebo Comparator
干预措施: This group of participants take ZL-65 placebo tablet (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: day 1 to day 7
次要结局
- ZL65 Pharmacokinetics (PK)：AUC0-∞(0-72hours)
- ZL65 Pharmacokinetics (PK)：t1/2(0-72hours)
- ZL65 Pharmacokinetics (PK)：Cmax(0-72hours)
- ZL65 Pharmacokinetics (PK)：Tmax(0-72hours)
- ZL65 Pharmacokinetics (PK)：AUC0-t(0-72hours)
研究者
研究点 (1)
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