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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07758101). StuddyBuddy aggregates publicly available trial information.