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To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04592835
Enrollment
24
Registered
2020-10-19
Start date
2020-10-19
Completion date
2021-06-30
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Patients

Brief summary

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

Interventions

DRUGDWRX2003

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

Sponsors

Novotech (Australia) Pty Limited
CollaboratorINDUSTRY
Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Treatment-Emergent Adverse Eventsfollow-up 35 days after dosingIncidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary

MeasureTime frameDescription
To assess PK parameters of niclosamide injectable (DWRX2003) through Cmaxat Day 1, 2, 3, 5, 7, 10, 14, 21 and 28Measured through Maximum (peak) plasma drug concentration (Cmax)
To assess PK parameters of niclosamide injectable (DWRX2003) through tmaxat Day 1, 2, 3, 5, 7, 10, 14, 21 and 28Time to reach Cmax following IP administration (tmax)
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-lastat Day 1, 2, 3, 5, 7, 10, 14, 21 and 28Area under the curve from zero to time of last measurable concentration (AUC0-last)
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28Area under the curve from zero to infinity (AUC0-∞)
To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28Elimination half-life (t1/2)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026