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A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease

RecruitingPhase 1Ages 18 Years - 55 YearsAllGuangdong Hengrui Pharmaceutical Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- Part 1 * Voluntarily signed the informed consent form * Age from 18 to 55 years old * Body weight โ‰ฅ45 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
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What it tests

  • SHR-7590
  • Placebo
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Where

1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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