To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04541485

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Patients	Drug: DWRX2003 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients

Actual Study Start Date :

Dec 4, 2020

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Mar 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Cohort 1 (96 mg) 24 mg/0.1 mL x 4 sites	Drug: DWRX2003 Intramuscularly injection at pre-defined injection sites Drug: Placebo Intramuscularly injection at pre-defined injection sites
Experimental: Experimental: Cohort 2 (288 mg) 72 mg/0.3 mL x 4 sites	Drug: DWRX2003 Intramuscularly injection at pre-defined injection sites Drug: Placebo Intramuscularly injection at pre-defined injection sites
Experimental: Experimental: Cohort 3 (480 mg) 120 mg/0.5 mL x 4 sites	Drug: DWRX2003 Intramuscularly injection at pre-defined injection sites Drug: Placebo Intramuscularly injection at pre-defined injection sites
Experimental: Experimental: Cohort 4 (672 mg) 168 mg/0.7 mL x 4 sites	Drug: DWRX2003 Intramuscularly injection at pre-defined injection sites Drug: Placebo Intramuscularly injection at pre-defined injection sites
Experimental: Experimental: Cohort 5 (960 mg) 240 mg/1.0 mL x 4 sites	Drug: DWRX2003 Intramuscularly injection at pre-defined injection sites Drug: Placebo Intramuscularly injection at pre-defined injection sites

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [follow-up 42 days after dosing]
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen [follow-up 42 days after dosing]
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen [at Day 3, 7, 10 and 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between 18 and 65 years of age, inclusive at time of signing the ICF.
Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.

Exclusion Criteria:

History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deawoong pharmaceutical	Seoul	Gangnam-gu	Korea, Republic of	06170

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04541485

Other Study ID Numbers:

DW_DWJ1516101_Phillipphines

First Posted:

Sep 9, 2020

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 23, 2021