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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Enrollment increased: 64 → 88 participants · Start date changed from estimate of Aug 2026 to Aug 21, 2026 · Eligibility criteria expanded, about 15 words · 3 more Show 6 more changesShow less
    • Enrollment increased: 64 → 88 participants
    • Start date changed from estimate of Aug 2026 to Aug 21, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Site details revised
    • Study title expanded, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07758101
Lead Sponsor Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions Moderate-to-severe Inflammatory Bowel Disease
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov