NCT07758101RecruitingPhase 1
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 21 Aug 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07758101
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 88
- From 21 Aug 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- \- Part 1
Who the study is looking for
- \- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.