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This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-1186 | Experimental | Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or 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 HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort |
|
| HL-1186 placebo | Placebo Comparator | Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or 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 HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-1186 | Drug | HL-1186 tablet for oral administration. |
| |
| HL-1186 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants | Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function | Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetic parameters of HL-1186 in healthy participants | Time to reach maximum concentration (Tmax) | Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20 |
| To assess the pharmacokinetic parameters of HL-1186 in healthy participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kangli Ma | Contact | 021-64311017 | clinical_trial@hllife.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangnan University Affiliated Hospital | Recruiting | Wuxi | China |
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| Drug |
HL-1186 placebo tablet for oral administration. |
|
Maximum concentration (Cmax) |
| Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20 |
| To assess the pharmacokinetic parameters of HL-1186 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 day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20 |
| To assess the pharmacokinetic parameters of HL-1186 in healthy participants | Elimination half time (T1/2) | Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20 |