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The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with JYP0061 orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.
This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and 5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:JYP0061 15mg | Experimental | Experimental: JYP0061 Single ascending dose |
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| Group B:JYP0061 placebo comparator 15mg | Placebo Comparator | Placebo comparator: JYP0061 placebo comparator Single ascending dose |
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| Group C:JYP0061 food influence group 15mg | Experimental | Food influence group |
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| Group D:JYP0061 multiple ascending doses 30mg | Experimental | Multiple ascending doses |
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| Group E:JYP0061 placebo comparator food influence group 30mg | Placebo Comparator | Food influence group |
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| Group F:JYP0061 placebo comparator multiple ascending doses 30mg | Placebo Comparator | Multiple ascending doses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYP0061 | Drug | JYP0061 orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| The peak plasma concentration that JYP0061 achieves after dosing. | Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time to reach the maximum concentration of JYP0061 in the bloodstream after administration. | Time when the maximum concentration is achieved | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The total drug exposure of JYP0061 from administration to an extrapolated infinite time, as represented by the area under the concentration-time curve. | Area under the concentration-time curve from time zero to infinity.in healthy subjects. | up to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200020 | China |
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| placebo | Drug | Placebo orally administered |
|