Moderate to Severe Ulcerative Colitis
Conditions
Brief 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 ulcerative colitis.
Interventions
DRUGSHR-7590
SHR-7590
DRUGPlacebo
Placebo
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | From ICF signing date to Day 281 |
| Serious adverse events | From ICF signing date to Day 281 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration of SHR-7590 (Cmax) | From 0 hour date to Day 281 |
| Time to maximum observed concentration (Tmax) of SHR-7590 | 0 hour to Day 281 |
| Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590 | 0 hour to Day 281 |
| Area under the drug-time curve from time 0 to infinity of SHR-7590（AUC0-inf） | 0 hour to Day 281 |
| Half-life (T1/2) of SHR-7590 | 0 hour to Day 281 |
| Clearance (CL) of SHR-7590 | 0 hour to Day 281 |
| Apparent clearance（CL/F）of SHR-7590 | 0 hour to Day 281 |
| Volume of distribution （Vd）or apparent volume of distribution （Vd/F）of SHR-7590 | 0 hour to Day 281 |
Countries
China
Contacts
CONTACTSi Chen
Outcome results
None listed