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

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

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 Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: DWRX2003; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort 1 (144 mg); Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites	Drug: DWRX2003; Intramuscularly injection at pre-defined injection sites; Drug: Placebo; Intramuscularly injection at pre-defined injection sites
Experimental: cohort 2 (432 mg); Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites	Drug: DWRX2003; Intramuscularly injection at pre-defined injection sites; Drug: Placebo; Intramuscularly injection at pre-defined injection sites
Experimental: cohort 3 (960 mg); Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites	Drug: DWRX2003; Intramuscularly injection at pre-defined injection sites; Drug: Placebo; Intramuscularly injection at pre-defined injection sites
Experimental: cohort 4 (1200 mg); Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites	Drug: DWRX2003; Intramuscularly injection at pre-defined injection sites; Drug: Placebo; Intramuscularly injection at pre-defined injection sites

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DWJ1516101_India

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No