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This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | SAD dose 1 |
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| SAD Cohort 2 | Experimental | SAD dose 2 |
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| SAD Cohort 3 | Experimental | SAD dose 3 |
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| SAD Cohort 4 | Experimental | SAD dose 4 |
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| SAD Cohort 5 | Experimental | SAD dose 5 |
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| MAD Cohort 1 | Experimental | MAD dose 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YP05002 | Drug | Tablet, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD) | Up to Day 14 | |
| Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD) | Up to Day 41 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of YP05002 (SAD) | PK parameters of YP05002 | Up to Day 14 |
| Cmax of YP05002 (MAD) | PK parameters of YP05002 | Up to Day 41 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yalei Xie | Contact | +86 23 63211443 | xieyl@yaopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Melbourne Clinic | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| MAD Cohort 2 |
| Experimental |
MAD dose 2 |
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| MAD Cohort 3 | Experimental | MAD dose 3 |
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| Placebo | Other | Tablet, QD |
|