A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in He… (NCT05656274) | Clinical Trial Compass
CompletedPhase 1
A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects.
China48 participantsStarted 2022-11-29
Plain-language summary
The purpose of this study is to evaluate the safety，tolerability，and pharmacokinetics of multiple-accending dose of JS1-1-01。
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.