To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

Study Overview
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Brief Summary
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This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.

Official Title
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Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients

Conditions
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COVID-19 Patients

Intervention / Treatment
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* Drug: DWRX2003
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 65 years of age, inclusive at time of signing the ICF. Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment. Exclusion Criteria: History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee). Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Cohort 1 (96 mg)<br>24 mg/0.1 mL x 4 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: Experimental: Cohort 2 (288 mg)<br>72 mg/0.3 mL x 4 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: Experimental: Cohort 3 (480 mg)<br>120 mg/0.5 mL x 4 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: Experimental: Cohort 4 (672 mg)<br>168 mg/0.7 mL x 4 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: Experimental: Cohort 5 (960 mg)<br>240 mg/1.0 mL x 4 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 42 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen |  | follow-up 42 days after dosing | 
| Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen |  | at Day 3, 7, 10 and 14 |