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NCT07758101
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
Conditions: Moderate-to-severe Inflammatory Bowel Disease
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 88
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Location: The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
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
Source: ClinicalTrials.gov (NCT07758101). StuddyBuddy aggregates publicly available trial information.