To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: COVID-19 Patients

Treatments: Drug: DWRX2003

Study type: Interventional

Funder types: Industry

Identifiers

NCT04592835

DW_DWJ1516101_Australia

Details and patient eligibility

About

This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken

Exclusion criteria

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort 1 (288mg)

Experimental group

Description:

72 mg/0.3 mL x 4 injection sites

Treatment:

Drug: DWRX2003

Cohort 2 (576 mg)

Experimental group

Description:

144 mg/0.6 mL x 4 injection sites

Treatment:

Drug: DWRX2003

Cohort 3 (960 mg)

Experimental group

Description:

216 mg/1.0 mL x 4 injection sites

Treatment:

Drug: DWRX2003