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| Name | Class |
|---|---|
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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The primary objective of this study is to assess the effect of a therapeutic and supratherapeutic oral dose of JMKX003142 on the corrected cardiac QT interval relative to a placebo in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003142 tablets | Drug | Participants will receive single of JMKX003142 6mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc) | Up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment | Up to 72 hours post dose | |
| Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment | Up to72 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| JMKX003142 tablets |
| Drug |
Participants will receive single of JMKX003142 30mg |
|
| Placebo | Drug | Participants will receive single of Placebo |
|
| Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment | Up to 72 hours post dose |
| Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence | Up to 72 hours post dose |
| Incidence of adverse events to assess the safety of single-dose administration of JMKX003142 | Up to 72 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) of JMKX003142 | Up to 72 hours post dose |
| Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142 | Up to 72 hours post dose |
| Apparent Terminal Elimination Half-life (T1/2) of JMKX003142 | Up to 72 hours post dose |
| Area Under the Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) for JMKX003142 | Up to 72 hours post dose |
| AUC From Time 0 to Infinity (AUCinf) for JMKX003142 | Up to 72 hours post dose |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |