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This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose(SAD) Treatment 1 | Experimental | WS016 single dose(6g) |
|
| SAD Treatment 2 | Experimental | WS016 single dose(12g) |
|
| SAD Treatment 3 | Experimental | WS016 single dose(24g) |
|
| SAD Treatment 4 | Experimental | WS016 single dose(36g) |
|
| SAD Treatment 5 | Experimental | WS016 single dose(48g) |
|
| SAD matching placebo | Placebo Comparator | SAD Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WS016 Single Dose(6g) | Drug | WS016 6g, to be administered orally as a single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose | Incidence, severity and causality of AEs and SAEs | up to Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Xiaoshan Hospital | Hangzhou | Zhejiang | 310000 | China |
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| Multiple Ascending Dose(MAD) Treatment 1 | Experimental | WS016 multiple dose(MAD Low Dose) |
|
| MAD Treatment 2 | Experimental | WS016 multiple dose(MAD Medium Dose) |
|
| MAD Treatment 3 | Experimental | WS016 multiple dose(MAD High Dose) |
|
| MAD matching placebo | Placebo Comparator | MAD matching placebo |
|
| WS016 Single Dose(12g) | Drug | WS016 12g, to be administered orally as a single dose. |
|
| WS016 Single Dose(24g) | Drug | WS016 24g, to be administered orally as a single dose. |
|
| WS016 Single Dose(36g) | Drug | WS016 36g, to be administered orally as a single dose. |
|
| WS016 Single Dose(48g) | Drug | WS016 48g, to be administered orally as a single dose. |
|
| SAD matching placebo | Drug | Matching placebo, to be administered orally as a single dose. |
|
| WS016 Multiple Dose(12g) | Drug | WS016 12g, to be administered orally once daily for a consecutive period of 7 days. |
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| WS016 Multiple Dose(24g) | Drug | WS016 24g, to be administered orally once daily for a consecutive period of 7 days. |
|
| WS016 Multiple Dose(48g) | Drug | WS016 48g, to be administered orally once daily for a consecutive period of 7 days. |
|
| MAD matching placebo | Drug | Matching placebo, to be administered orally once daily for a consecutive period of 7 days. |
|
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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