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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults aged 18 to 55 to test the safety of SHR-7590. The record lists only the rules for the first part of the study.
- Age
- 18 to 55 years
- Sex
- All sexes can join.
- Earlier treatment
- Part 1: cannot have used immunosuppressant or anti-interleukin antibody drugs in the 6 months before screening.
Main reasons for not taking part
- Suspected allergy to the study drug or any part of it
- History of cancer (malignant tumor)
- Opportunistic infection in the 6 months before screening
- Took part in another drug or device trial in the 3 months before screening
- Major trauma or major surgery in the 6 months before screening, or surgery planned during the trial
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.