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

NCT04524052 | Unknown Phase 1

• 1 other identifier: DWJ1516101_India
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

  follow-up 48 days after dosing

Secondary Outcomes (3)

• pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax

  follow-up 48 days after dosing

• pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax

  follow-up 48 days after dosing

• pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP

  on Day 3, 7, 10 and 14

Study Arms (4)

cohort 1 (144 mg)

EXPERIMENTAL

Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites

Drug: DWRX2003; Drug: Placebo

cohort 2 (432 mg)

EXPERIMENTAL

Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites

Drug: DWRX2003; Drug: Placebo

cohort 3 (960 mg)

EXPERIMENTAL

Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites

Drug: DWRX2003; Drug: Placebo

cohort 4 (1200 mg)

EXPERIMENTAL

Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites

Drug: DWRX2003; Drug: Placebo

Interventions

DWRX2003 DRUG

Intramuscularly injection at pre-defined injection sites

cohort 1 (144 mg); cohort 2 (432 mg); cohort 3 (960 mg); cohort 4 (1200 mg)

Placebo DRUG

Intramuscularly injection at pre-defined injection sites

cohort 1 (144 mg); cohort 2 (432 mg); cohort 3 (960 mg); cohort 4 (1200 mg)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
• Volunteers who agree to give written informed consent and are willing to participate in the study.
• Volunteer having bodyweight minimum of 50 kg.
• Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).

You may not qualify if:

• Known allergic to Niclosamide or any component of the formulation and to any other related drug.
• History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
• Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
• History/ current use of Alcohol or drug abuse.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share