NCT05656274已完成1 期
A Phase 1b，Randomized, Investigator/Participant-Blind, Placebo-Controlled, Multiple-Ascending Dose Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of JS1-1-01 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety，tolerability，and pharmacokinetics of multiple-accending dose of JS1-1-01。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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 male or female participants 18 to 45 years of age.
- •Body weight ≥ 50 kg ; body mass index of 19 to 28 kg/m^2 ;
- •Subjects have no birth plan and voluntarily take effective contraceptive measures within 3 months after signing the informed consent form and the last medication;
- •Willing and able to sign the informed consent form, and understand and abide by the research procedures.
排除标准
- •Allergic constitution or a history of food and drug allergy;
- •According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation;
- •There are neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, blood and lymphatic, endocrine, skeletal and muscular diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the study;
- •The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant;
- •HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive;
- •Pregnant or lactating women;
- •A History of drug abuse, or positive urine drug abuse screening;
- •Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period;
- •In recent three months, the amount of alcohol consumed per week exceeded 14 units of alcohol , or the alcohol breath test was positive, or alcohol consumption was prohibited from 48 hours before the first administration to the end of the test;
- •Those who have taken any drugs within 4 weeks before the first administration (including prescription drugs, over-the-counter drugs, Chinese herbal medicine, vitamins, calcium tablets and other food supplements);
- •Difficulty in blood collection and history of blood sickness and needle sickness;
- •Those who have special requirements on diet and can not follow the unified diet, or are prone to diarrhea, nausea, vomiting, abdominal distension or other gastrointestinal discomfort after drinking milk or dairy products;
- •From 48 hours before the first administration to the end of the study, the subjects refused to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc;
- •From 7 days before the first administration to the end of the study, the subjects refused to stop using any drink or food containing grapefruit;
- •Participated in any drug clinical trial and took the test drug in recent 3 months; Or those who plan to participate in other clinical trials during the trial
- •Those who have donated blood or lost blood ≥ 200 mL or received blood transfusion or used blood products in recent 3 months; Or those who plan to donate blood during the trial;
- •The researchers believe that the subjects have poor compliance or other clinical, social or family factors that are not suitable for inclusion.
研究组 & 干预措施
JS1-1-01
Experimental
JS1-1-01 25mg，50mg，100mg，150mg
干预措施: JS1-1-01 (Drug)
Placebo
Placebo Comparator
placebo 25mg，50mg，100mg，150mg
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: day 11
To evaluate the safety and tolerability of JS1-1-01 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG)
次要结局
- Pharmacokinetics profile after a single dose(day 1)
- Pharmacokinetics profile after multiple dosing.(day 11)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)NCT02698657Astellas Pharma Global Development, Inc.30
已完成
1 期
TAK-935 Multiple Rising Dose Study in Healthy ParticipantsEpilepsyNCT02539134Takeda40
已完成
1 期
Multiple Dose Safety Study of PF-04802540 in Subjects With SchizophreniaSchizophreniaNCT00876304Taisho Pharmaceutical Co., Ltd.39
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy ParticipantsHealthy VolunteersNCT02389881Takeda40
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy SubjectsHealthy VolunteersNCT03351751Pfizer19