Official Title
A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers
Brief Summary

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

Unknown status
COVID-19 Patients

Drug: DWRX2003

Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Novotech (Australia) Pty Limited
NCT Number