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 ulcerative colitis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Adverse events — From ICF signing date to Day 281
Serious adverse events — From ICF signing date to Day 281
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Guangdong Hengrui Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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