A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-Severe Ulcerative Colitis

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SHR-7590
  • Placebo

Treatment groups

64 Participants
are divided into 5 treatment groups