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To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.

NCT04749173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-13

No results posted yet for this study

Summary

This Phase I study is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability and PK profile of single intramuscular doses of DWRX2003 in healthy volunteers.

Conditions

  • Covid19

Interventions

DRUG

DWRX2003, 96mg

Drug: Placebo Intramuscularly injection at predefined injection sites

DRUG

DWRX2003, 432mg

Drug: Placebo Intramuscularly injection at predefined injection sites

DRUG

DWRX2003, 144mg

Drug: Placebo Intramuscularly injection at predefined injection sites

DRUG

DWRX2003, 144mg

Drug: Placebo Intramuscularly injection at predefined injection sites

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-21
Primary Completion
2021-06-18
Completion
2021-06-18

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749173 on ClinicalTrials.gov