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This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 (144 mg) | Experimental | Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites |
|
| cohort 2 (432 mg) | Experimental | Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites |
|
| cohort 3 (960 mg) | Experimental | Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites |
|
| cohort 4 (1200 mg) | Experimental | Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWRX2003 | Drug | Intramuscularly injection at pre-defined injection sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) | follow-up 48 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax | Maximum measured plasma concentration over the time span specified | follow-up 48 days after dosing |
| pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | Intramuscularly injection at pre-defined injection sites |
|
Time of the maximum measured plasma concentration |
| follow-up 48 days after dosing |
| pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP | Change in C reactive protein levels | on Day 3, 7, 10 and 14 |