Safety test of SHR-7590 in healthy adults and adults with moderate-to-severe inflammatory bowel disease
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection or Intravenous Infusion of SHR-7590 Injection in Healthy Chinese Participants and Participants With Moderate-to-Severe Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)
Run by Guangdong Hengrui Pharmaceutical Co., Ltd · NCT07758101 · Data updated 2026-11-12
This early human study tests whether SHR-7590 is safe and tolerable in healthy adults and in adults with moderate-to-severe inflammatory bowel disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | August 21, 2026 |
| Main results expected | January 2027 |
| Study ends | December 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07758101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-55 with BMI 18-26 kg/m2 who are either healthy or have moderate-to-severe inflammatory bowel disease and can use contraception.
✕Probably not a fit
Patients with serious infections, recent malignancy, major comorbid conditions, or recent immunosuppressant or anti-interleukin drug use may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, first-in-human study that investigates safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 given by injection or IV. Participants include Chinese healthy volunteers and patients with moderate-to-severe inflammatory bowel disease. The study uses SHR-7590 and placebo, with careful screening and exclusion criteria to minimize risk. The trial is conducted at a leading Chinese medical institution with sponsor Guangdong Hengrui Pharmaceutical Co., Ltd.
Why it matters
Potential benefit: If successful, SHR-7590 could advance understanding of safety and dosing for future development in inflammatory bowel disease.
How similar studies have gone: Phase 1 studies of similar agents have shown that early safety and PK/PD profiling can guide later development, though specifics for SHR-7590 are novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Si Chen
- Email: si.chen@hengrui.com
- Phone: 0518-82342973
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.