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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
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-08-21
Completion Date
2027-12
Last Updated
2026-09-25
Healthy Volunteers
Yes
Interventions
SHR-7590
SHR-7590
Placebo
Placebo
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China