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This study is a single-center, single- and multiple-dose escalating study with a food-effect component, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of YD0293 tablets following a single oral dose in healthy subjects, as well as the effect of food on PK parameters and the potential effect on the QT interval. The study also aims to assess the safety, tolerability, and PK profile of YD0293 tablets following multiple oral doses in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YD0293 | Experimental | Single dose ascending(SAD): participants will be randomized to receive a single dose of YD0293, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Multiple ascending dose(MAD): participants will be randomized to receive muliple doses of YD0293, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of YD0293. |
|
| YD0293 placebo | Placebo Comparator | Single dose ascending(SAD): participants will be randomized to receive a single dose of placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Multiple ascending dose(MAD): participants will be randomized to receive muliple doses of placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of YD0293. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YD0293 | Drug | YD0293 tablet for oral administration |
| |
| YD0293 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of YD0293 in healthy participants | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Single ascending dose(SAD): day1 to day15; Multiple ascending dose(MAD): day1 to day39; Food effect(FE): day1 to day21 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetic parameters of YD0293 in healthy participants | Time to reach maximum concentration (Tmax) | Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11 |
| To assess the pharmacokinetic parameters of YD0293 in healthy participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Pan | Second Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| Drug |
YD0293 placebo tablet for oral administration |
|
Maximum concentration (Cmax) |
| Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11 |
| To assess the pharmacokinetic parameters of YD0293 in healthy participants | Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t) | Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11 |
| To assess the pharmacokinetic parameters of YD0293 in healthy participants | Elimination half time (T1/2) | Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11 |
| To assess the changes in QT/QTc intervals following a single oral dose of YD0293 tablets | Single ascending dose(SAD): day1 to day2 |
| To assess the pharmacodynamic characteristic of YD0293 in healthy participants | Change in active neutrophil elastase concentrations in blood after multiple oral doses of YD0293 from baseline | Multiple ascending dose(MAD): day1 to day32 |