A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With M… (NCT07758101) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-Severe Ulcerative Colitis
China64 participantsStarted 2026-08
Plain-language summary
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe ulcerative colitis.
Who can participate
Age range
18 Years – 55 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:
\- Part 1
* Voluntarily signed the informed consent form
* Age from 18 to 55 years old
* Body weight ≥45 kg, body mass index (BMI) 18-26 kg/m2
* Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations
* Adopt efficient contraceptive measures
Exclusion Criteria:
\- Part 1
* Suspected allergy to the study drug or any component of the study drug
* Any clinical disease or any other disease that could interfere with the test results
* Had a history of malignant tumor
* Had an opportunistic infection within 6 months before screening
* Acute infection with constitutional symptoms within 4 weeks before baseline
* Participants who participated in any drug or device clinical trial within 3 months before screening
* Use of any drug within 1 month before the use of the investigational drug
* Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening
* Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial
* History of blood donation within 1 month before screening, or severe blood loss
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.