To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003
Study Details
Study Description
Brief Summary
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 (288mg) 72 mg/0.3 mL x 4 injection sites |
Drug: DWRX2003
Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
|
| Experimental: Cohort 2 (576 mg) 144 mg/0.6 mL x 4 injection sites |
Drug: DWRX2003
Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
|
| Experimental: Cohort 3 (960 mg) 216 mg/1.0 mL x 4 injection sites |
Drug: DWRX2003
Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [follow-up 35 days after dosing]
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
- To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax [at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28]
Measured through Maximum (peak) plasma drug concentration (Cmax)
- To assess PK parameters of niclosamide injectable (DWRX2003) through tmax [at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28]
Time to reach Cmax following IP administration (tmax)
- To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last [at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28]
Area 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 28]
Area under the curve from zero to infinity (AUC0-∞)
- To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2 [at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28]
Elimination half-life (t1/2)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
-
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).
-
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:
-
Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
-
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).
-
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Novotech (Australia) Pty Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWJ1516101_Australia