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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (288mg) | Experimental | 72 mg/0.3 mL x 4 injection sites |
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| Cohort 2 (576 mg) | Experimental | 144 mg/0.6 mL x 4 injection sites |
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| Cohort 3 (960 mg) | Experimental | 216 mg/1.0 mL x 4 injection sites |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWRX2003 | Drug | Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) | follow-up 35 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax | Measured through Maximum (peak) plasma drug concentration (Cmax) | at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 |
| To assess PK parameters of niclosamide injectable (DWRX2003) through tmax |
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Inclusion Criteria:
Exclusion Criteria:
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Time to reach Cmax following IP administration (tmax) |
| at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 |
| To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last | Area under the curve from zero to time of last measurable concentration (AUC0-last) | at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 |
| To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞ | Area under the curve from zero to infinity (AUC0-∞) | at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 |
| To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2 | Elimination half-life (t1/2) | at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 |