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This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WD-910 Take a fixed dose of WD-910 tablets orally | Experimental |
| |
| WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WD-910 tablet | Drug | Administered P.O. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AEs) | A single-ascending dose (SAD) study :up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks | |
| Number of participants with abnormal lab values | SAD :up to 1week; MAD and FE : up to2weeks | |
| Single Ascending Dose Cohorts : Cmax | From Day1 to Day3 | |
| Single Ascending Dose Cohorts : AUC0-∞ | From Day1 to Day3 | |
| Single Ascending Dose Cohorts : Tmax | From Day1 to Day3 | |
| Single Ascending Dose Cohorts : t½ | From Day1 to Day3 | |
| Multiple Ascending Dose Cohorts: Cmax,ss | Day1 , Day10 | |
| Multiple Ascending Dose Cohorts: Cmin,ss | Day1 , Day10 | |
| Multiple Ascending Dose Cohorts: Cavg,ss | Day1 , Day10 | |
| Multiple Ascending Dose Cohorts: Tmax,ss | Day1 , Day10 | |
| Multiple Ascending Dose Cohorts: AUC0-τ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arockiaa Joseph | Contact | +61 459 661 281 | c.trollip@nucleusnetwork.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia |
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| WD-910 Tablets Placebo |
| Drug |
Administered P.O. |
|
| Day1 , Day10 |
| Multiple Ascending Dose Cohorts: t½, | Day1 , Day10 |
| Food Effect Cohorts: Cmax | From Day1 to Day4 , From Day8 to Day11 |
| Food Effect Cohorts: Tmax | From Day1 to Day4 , From Day8 to Day11 |
| Food Effect Cohorts: AUC0-t | From Day1 to Day4 , From Day8 to Day11 |