To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers

Conditions
-----------------
COVID-19 Patients

Intervention / Treatment
-----------------
* Drug: DWRX2003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF). Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive). Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken Exclusion Criteria: Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee). Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (288mg)<br>72 mg/0.3 mL x 4 injection sites | Drug: DWRX2003<br>* Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites<br>|
| Experimental: Cohort 2 (576 mg)<br>144 mg/0.6 mL x 4 injection sites | Drug: DWRX2003<br>* Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites<br>|
| Experimental: Cohort 3 (960 mg)<br>216 mg/1.0 mL x 4 injection sites | Drug: DWRX2003<br>* Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites<br>|

What is the study measuring?
-----------------
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 35 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |