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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.
This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10506 | Experimental | Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. |
|
| HS-10506 Placebo | Experimental | Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10506 | Drug | HS-10506 will be administered orally once on Day 1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug | 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. | Screening until Trail phase (up to 5 weeks) |
| Number of participants with clinically significant change from baseline in vital signs | From baseline to Day 3 | |
| Number of participants with clinically significant abnormalities in physical examination | From baseline to Day 3 | |
| Changes in 12-lead electrocardiogram from before to after dosing | Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point. | From baseline to Day 3 |
| Change in Stanford Sleepiness Scale score from before to after dosing | Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point. | From baseline to 4 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Observed maximum plasma concentration (Cmax) | Cmax will be obtained following administration of a single oral dose of HS-10506. | up to 48 hours after dosing |
| Time to reach maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang Li | Contact | 021-34773128 | lhlh_5@163.com |
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| HS-10506 Placebo |
| Drug |
Matching placebo will be administered orally once on Day 1. |
|
Tmax will be obtained following administration of a single oral dose of HS-10506.
| up to 48 hours after dosing |
| Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t） | Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）will be obtained following administration of a single oral dose of HS-10506. | up to 48 hours after dosing |
| Area under the concentration-time curve from time zero to infinity（AUC0-∞） | AUC0-t will be obtained following administration of a single oral dose of HS-10506. | up to 48 hours after dosing |
| Terminal Rate Constant（λz） | Terminal Rate Constant（λz） will be obtained following administration of a single oral dose of HS-10506. | up to 48 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-10506. | up to 48 hours after dosing |
| Apparent clearance（CL/F） | CL/F will be obtained following administration of a single oral dose of HS-10506. | up to 48 hours after dosing |
| Apparent Volume of Distribution（Vd/F） | Vd/F will be obtained following administration of a single oral dose of HS-10506. Time Frame: up to 48 hours after dosing | up to 48 hours after dosing |
| Mean Residence Time(MRT) | RT will be obtained following administration of a single oral dose of HS-10506. | up to 48 hours after dosing |