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The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose of HS-10501 administered orally under fasted conditions |
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| Cohort 2 | Experimental | Single dose of HS-10501 administered orally under fasted conditions |
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| Cohort 3 | Experimental | Single dose of HS-10501 administered orally under fed and fasted conditions |
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| Cohort 4 | Experimental | Single dose of HS-10501 administered orally under fasted conditions |
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| Cohort 5 | Experimental | Single dose of HS-10501 administered orally under fasted conditions |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10501 tablet | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect. | Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35. |
| Number of participants with clinically significant abnormalities in lab tests | Laboratory tests include blood routine, urine routine, blood biochemistry and coagulation function, etc. | Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35. |
| Number of participants with clinically significant change from baseline in vital signs | Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35. | |
| Change from baseline in Electrocardiogram (ECG) | ECG parameters including heart rate, PR interval, QRS interval and QTcF, etc. | Day1 to last follow-up, SAD: Baseline to Day 8; MAD: Baseline to Day 35. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of HS-10501 - AUC0-t | Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hu, MD | Contact | (+86)13856086475 | ayefygcp@163.com | |
| Yijun Du, MD | Contact | (+86)13866700016 | 2460679232@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of Anhui University | Recruiting | Hefei | Anhui | 230601 | China |
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Single dose of HS-10501 administered orally under fasted conditions
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| Cohort 7 | Experimental | Drugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day. |
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| Cohort 8 | Experimental | Drugs are given once a day (QD) for 28 days. |
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| Cohort 9 | Experimental | Drugs are given twice a day (BID) for 27 days, and only one morning dose is given on the 28th day. |
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| Placebo | Drug | Administered orally |
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Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);
| pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501 - Cmax | Maximum observed concentration (Cmax) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501 - Tmax | Time to maximum observed concentration (Tmax) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501 - t1/2 | Terminal elimination half-life (t1/2) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501 - CL/F | Apparent clearance (CL/F) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501- Vz/F | Apparent volume of distribution (Vz/F) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501-λz | elimination rate constant (λz) | pre-dose to 72 hours post-dose |
| Pharmacokinetic (PK) profile of HS-10501- AUC0-τ | area under plasma concentration-time curve within a dosing interval | pre-dose to 72 hours post-dose |
| Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT) | Area under the glucose-time curve from time zero to the last quantifiable time point t (AUC0-t) after oral glucose tolerance test (OGTT) | before to 3 hours after the first intake of glucose on Day-1,Day 1 and Day 28 |
| Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT) | Area under the insulin-time curve from time zero to the last quantifiable time point t (AUC0-t) after oral glucose tolerance test (OGTT) | before to 3 hours after the first intake of glucose on Day-1,Day 1 and Day 28 |
| body weight changes | Change in body weight from baseline after treatment | from day-1to day 28 |