To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: DWRX2003

Study type: Interventional

Funder types: Industry

Identifiers

NCT04524052

DWJ1516101_India

Details and patient eligibility

About

This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
2. Volunteers who agree to give written informed consent and are willing to participate in the study.
3. Volunteer having bodyweight minimum of 50 kg.
4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).

Exclusion criteria

1. Known allergic to Niclosamide or any component of the formulation and to any other related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
3. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
4. History/ current use of Alcohol or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

cohort 1 (144 mg)

Experimental group

Description:

Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

cohort 2 (432 mg)

Experimental group

Description:

Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

cohort 3 (960 mg)

Experimental group

Description:

Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites

Treatment:

Drug: DWRX2003

Drug: Placebo

cohort 4 (1200 mg)

Experimental group

Description:

Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites

Treatment:

Drug: DWRX2003

Drug: Placebo