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

Daewoong Pharmaceutical Co. LTD.32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

DWRX2003DRUG

Intramuscularly injection at pre-defined injection sites

PlaceboDRUG

Intramuscularly injection at pre-defined injection sites

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age. 2. Volunteers who agree to give written informed consent and are willing to participate in the study. 3. Volunteer having bodyweight minimum of 50 kg. 4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive). Exclusion Criteria: 1. Known allergic to Niclosamide or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. 3. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test. 4. History/ current use of Alcohol or drug abuse.

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Time frame: follow-up 48 days after dosing

Secondary Outcomes

pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax

Maximum measured plasma concentration over the time span specified

Time frame: follow-up 48 days after dosing

pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax

Time of the maximum measured plasma concentration

Time frame: 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

Time frame: on Day 3, 7, 10 and 14

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.