NCT07758101 A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
| NCT ID | NCT07758101 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Condition | Moderate-to-severe Inflammatory Bowel Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-08-21 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 88 participants in total. It began in 2026-08-21 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 inflammatory bowel disease.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07758101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Moderate-to-severe Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07758101 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07758101 currently recruiting?
Yes, NCT07758101 is actively recruiting participants. Contact the research team at si.chen@hengrui.com for enrollment information.
Where is the NCT07758101 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07758101 clinical trial?
NCT07758101 is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. The trial plans to enroll 88 participants.