To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

Phase 1

• Conditions: COVID-19 Patients
• Interventions: Drug: DWRX2003

• Registration Number: NCT04592835
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study Start: 2020-10-19
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2020-12-13
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3 (960 mg)	DWRX2003	216 mg/1.0 mL x 4 injection sites
Cohort 1 (288mg)	DWRX2003	72 mg/0.3 mL x 4 injection sites
Cohort 2 (576 mg)	DWRX2003	144 mg/0.6 mL x 4 injection sites

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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-∞	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)
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 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)