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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGAdverse events
Time frame: From ICF signing date to Day 281
Serious adverse events
Time frame: From ICF signing date to Day 281
Maximum observed concentration of SHR-7590 (Cmax)
Time frame: From 0 hour date to Day 281
Time to maximum observed concentration (Tmax) of SHR-7590
Time frame: 0 hour to Day 281
Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590
Time frame: 0 hour to Day 281
Area under the drug-time curve from time 0 to infinity of SHR-7590(AUC0-inf)
Time frame: 0 hour to Day 281
Half-life (T1/2) of SHR-7590
Time frame: 0 hour to Day 281
Clearance (CL) of SHR-7590
Time frame: 0 hour to Day 281
Apparent clearance(CL/F)of SHR-7590
Time frame: 0 hour to Day 281
Volume of distribution (Vd)or apparent volume of distribution (Vd/F)of SHR-7590
Time frame: 0 hour to Day 281
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