Safety of SHR-7590 in healthy people and in people with inflammatory bowel disease
Tests SHR-7590 in healthy adults and adults with inflammatory bowel disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07758101, who can take part
Where in China
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Trial code
- NCT07758101
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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; Part 1.