To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

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

This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.

Study Overview

• Status: Unknown
• Conditions: COVID-19 Patients
• Intervention / Treatment: Drug: DWRX2003

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
2. 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).
3. 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:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. 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).
3. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1 (288mg); 72 mg/0.3 mL x 4 injection sites	Drug: DWRX2003; Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites
EXPERIMENTAL: Cohort 2 (576 mg); 144 mg/0.6 mL x 4 injection sites	Drug: DWRX2003; Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites
EXPERIMENTAL: Cohort 3 (960 mg); 216 mg/1.0 mL x 4 injection sites	Drug: DWRX2003; Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Collaborators: Novotech (Australia) Pty Limited

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 19, 2020
• Primary Completion (ANTICIPATED): December 13, 2020
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1516101_Australia

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