A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation clinical trial. The primary objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple oral doses of HS-10398 in Chinese healthy participants. The secondary objective is to assess the impact of food on the pharmacokinetics of single oral doses of HS-10398 in Chinese healthy participants, as well as to evaluate the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
SAD:HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD:HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF:HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
SAD:HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD:HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14
The Affiliated Hospital of Qingdao University
Qingdao, China
Incidence and severity of adverse events (AEs)
The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: From screening to day 15
Serious adverse events (SAEs)
The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Time frame: From screening to day 15
Observed maximum plasma concentration (Cmax)
Cmax will be obtained following administration of a single oral dose of HS-10398
Time frame: up to 216 hours after dosing
Time to reach maximum plasma concentration (Tmax)
Tmax will be obtained following administration of a single oral dose of HS-10398
Time frame: up to 216 hours after dosing
Elimination Halflife (T1/2)
Elimination Halflife (T1/2) is the time measured for the concentration to decrease by one half which will be obtained following administration of a single oral dose of HS-10398
Time frame: up to 216 hours after dosing
Apparent clearance(CL/F)
CL/F will be obtained following administration of a single oral dose of HS-10398
Time frame: up to 216 hours after dosing
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Apparent Volume of Distribution(Vd/F)
Vd/F will be obtained following administration of a single oral dose of HS-10398
Time frame: up to 216 hours after dosing