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

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWRX2003; Drug: Placebo

• Registration Number: NCT04524052
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 4 (1200 mg)	Placebo	Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites
cohort 1 (144 mg)	DWRX2003	Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites
cohort 3 (960 mg)	Placebo	Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites
cohort 2 (432 mg)	Placebo	Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites
cohort 2 (432 mg)	DWRX2003	Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites
cohort 1 (144 mg)	Placebo	Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites
cohort 3 (960 mg)	DWRX2003	Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites
cohort 4 (1200 mg)	DWRX2003	Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	follow-up 48 days after dosing	AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax	follow-up 48 days after dosing	Maximum measured plasma concentration over the time span specified
pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP	on Day 3, 7, 10 and 14	Change in C reactive protein levels
pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax	follow-up 48 days after dosing	Time of the maximum measured plasma concentration