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
Brief Summary

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

Status
Terminated
Conditions
COVID-19 Patients
Interventions

Drug: DWRX2003

Intramuscularly injection at pre-defined injection sites

Drug: Placebo

Intramuscularly injection at pre-defined injection sites

Eligibility Criteria

Inclusion Criteria:

1. Between 18 and 65 years of age, inclusive at time of signing the ICF.

2. 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:

1. 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).

2. Significant history, clinical manifestation of any medical disorder or any comorbid
conditions which in the opinion of the investigator may interfere with the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Korea, Republic of
Locations

Deawoong pharmaceutical
Seoul, Gangnam-gu, Korea, Republic of

Sponsors / Collaborators
Daewoong Pharmaceutical Co. LTD.
NCT Number
NCT04541485
MeSH Terms
COVID-19