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This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mg CS0159 | Experimental | One tablet daily for seven days. |
|
| 4mg CS0159 | Experimental | Two tablet daily for seven days. |
|
| 6mg CS0159 | Experimental | Three tablet daily for seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS0159 | Drug | Tablets administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days. | Upto day 15 |
| Dose PK Parameter(C-max) | Evaluate the Peak Plasma Concentration. | day 1, day 7 |
| Dose PK Parameter(AUC) | Evaluate the Area under the plasma concentration versus time curve. | day 1, day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Food effect PK Parameter(C-max) | Evaluate the Peak Plasma Concentration. | day 10 |
| Food effect PK Parameter(AUC) | Evaluate the Area under the plasma concentration versus time curve. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Liu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| Placebo |
| Drug |
Tablets administered orally |
|
| day 10 |
| QTc analysis | analysize the plasma Concentration relevance to QTcF | day 1, day 7 |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |