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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10511 Tablets | Experimental | Subjects will be assigned to one of 5~6 planned dose cohorts in (single ascending dose)SAD and one of 4 planned dose cohorts in (multiple ascending dose)MAD. |
|
| HS-10511 Tablets Placebo | Placebo Comparator | Subjects will be assigned to one of 5~6 planned dose cohorts in SAD and one of 4 planned dose cohorts in MAD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10511 Tablets | Drug | HS-10511 tablets for 5~6 SAD cohorts and 4 MAD cohorts |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to day 8 |
| Number of participants with clinically significant change from baseline in vital signs in SAD | Day 1 to day 8 | |
| Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD | Day 1 to day 8 | |
| Number of participants with clinically significant abnormalities in laboratory examination in SAD | Day 1 to day 8 | |
| Number of participants with clinically significant abnormalities in physical examination in SAD | 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. |
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Inclusion Criteria:
Exclusion Criteria:
No less than 1/3 of either gender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Zhang | Contact | 010-82266876 | bysyec@163.com |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D009202 | Cardiomyopathies |
| D006984 | Hypertrophy |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| HS-10511 Tablets Placebo |
| Drug |
HS-10511 tablets placebo for 5~6 SAD cohorts and 4 MAD cohorts |
|
| Day 1 to Day 14 |
| Number of participants with clinically significant change from baseline in vital signs in MAD | Day 1 to Day 14 |
| Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD | Day 1 to Day 14 |
| Number of participants with clinically significant abnormalities in laboratory examination in MAD | Day 1 to Day 14 |
| Number of participants with clinically significant abnormalities in physical examination in MAD | Day 1 to Day 14 |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |