To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age. Volunteers who agree to give written informed consent and are willing to participate in the study. Volunteer having bodyweight minimum of 50 kg. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive). Exclusion Criteria: Known allergic to Niclosamide or any component of the formulation and to any other related drug. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test. History/ current use of Alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 (144 mg)<br>Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: cohort 2 (432 mg)<br>Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: cohort 3 (960 mg)<br>Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites | Drug: DWRX2003<br>* Intramuscularly injection at pre-defined injection sites<br>Drug: Placebo<br>* Intramuscularly injection at pre-defined injection sites<br>|
| Experimental: cohort 4 (1200 mg)<br>Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 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?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |