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 groupsSponsors and collaborators
Source ClinicalTrials.gov