Safety, Tolerability and Pharmacokinetic Characteristics of JYP0061 in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The peak plasma concentration that JYP0061 achieves after dosing.
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with JYP0061 orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.
详细描述
This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and 5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years old (including both endpoints), healthy males or females;
- •Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28kg/m^2 (including both endpoints);
- •No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and laboratory examination important indicators do not show clinically significant abnormalities;
- •The participants (including partners) have no plans for childbearing from screening to 90 days after the last administration of the study drug, and are willing to take appropriate effective contraceptive measures (non-oral contraceptives);
- •Fully understanding the study, voluntarily participate in the trial, and willingly sign the written informed consent.
排除标准
- •Pregnant or lactating women;
- •Individuals with special dietary requirements that cannot comply with a uniform diet;
- •Suspected or confirmed allergy to any ingredients similar to the study drug or any ingredient in the study drug, or individuals with a history of allergic reactions;
- •Past or current severe illness/abnormality (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant tumors, hematological, immune, rheumatological, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody; Participated in a clinical trial within the past 3 months;
研究组 & 干预措施
Group A:JYP0061 15mg
Experimental: JYP0061 Single ascending dose
干预措施: JYP0061 (Drug)
Group B:JYP0061 placebo comparator 15mg
Placebo comparator: JYP0061 placebo comparator Single ascending dose
干预措施: placebo (Drug)
Group C:JYP0061 food influence group 15mg
Food influence group
干预措施: JYP0061 (Drug)
Group D:JYP0061 multiple ascending doses 30mg
Multiple ascending doses
干预措施: JYP0061 (Drug)
Group E:JYP0061 placebo comparator food influence group 30mg
Food influence group
干预措施: placebo (Drug)
Group F:JYP0061 placebo comparator multiple ascending doses 30mg
Multiple ascending doses
干预措施: placebo (Drug)
结局指标
主要结局
The peak plasma concentration that JYP0061 achieves after dosing.
时间窗: up to 4 weeks
Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma
次要结局
- The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.(up to 4 weeks)