This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and PK and PD characteristics of HS-10511 in healthy adult subjects. This study consists of two parts: Part 1 is a single ascending dose (SAD) peroid in healthy subjects and Part 2 is a multiple ascending dose (MAD) period. Each period is composed of the screening, baseline, dosing and observation, and follow-up periods. All subjects will sign a written informed consent form (ICF) and will be assessed for eligibility criteria before entering the screening period (D-28-D-1). Subjects who meet all inclusion criteria and none of the exclusion criteria will be admitted in the baseline period (i.e., 1 day before dosing, D-1), undergo baseline assessment and randomization, complete dosing and the safety, tolerability, and PK and PD assessments within the given time period, and complete outpatient visits at the given follow-up time after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
HS-10511 tablets for 5\~6 SAD cohorts and 4 MAD cohorts
HS-10511 tablets placebo for 5\~6 SAD cohorts and 4 MAD cohorts
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in single ascending dose (SAD)
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. 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: Day 1 to day 8
Number of participants with clinically significant change from baseline in vital signs in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant abnormalities in laboratory examination in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant abnormalities in physical examination in SAD
Time frame: Day 1 to day 8
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in multiple ascending dose (MAD)
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. 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 14
Number of participants with clinically significant change from baseline in vital signs in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant abnormalities in laboratory examination in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant abnormalities in physical examination in MAD
Time frame: Day 1 to Day 14