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

Daewoong Pharmaceutical

Status and phase: Terminated; Phase 1

Conditions: COVID-19 Patients

Treatments: Drug: DWRX2003; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04541485

DW_DWJ1516101_Phillipphines

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 5 patient groups

Experimental: Cohort 1 (96 mg)

Experimental group

Description:

24 mg/0.1 mL x 4 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

Experimental: Cohort 2 (288 mg)

Experimental group

Description:

72 mg/0.3 mL x 4 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

Experimental: Cohort 3 (480 mg)

Experimental group

Description:

120 mg/0.5 mL x 4 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

Experimental: Cohort 4 (672 mg)

Experimental group

Description:

168 mg/0.7 mL x 4 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

Experimental: Cohort 5 (960 mg)

Experimental group

Description:

240 mg/1.0 mL x 4 sites

Treatment:

Drug: DWRX2003

Drug: Placebo