This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
dose 1 or dose 2
placebo
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Maximal Concentration (Cmax) of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Volume of Distribution (Vd/F) of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Half life time of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Clearance (CL/F) of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Accumulation Ratio of IBI353 and its related metabolites.
Time frame: Baseline through Day 21
Incidence of treatment-emergent adverse events (TEAEs), gastrointestinal AEs, and changes of vital signs, lab examinations, physical examinations, ECGs in healthy subjects after drug administration.
Time frame: Baseline through Day 28
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