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

Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers

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.

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.