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

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ClinicalTrials.gov Identifier: NCT04524052
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: DWRX2003 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: cohort 1 (144 mg)
Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: cohort 2 (432 mg)
Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: cohort 3 (960 mg)
Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: cohort 4 (1200 mg)
Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: follow-up 48 days after dosing ]
    AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax [ Time Frame: follow-up 48 days after dosing ]
    Maximum measured plasma concentration over the time span specified

  2. pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax [ Time Frame: follow-up 48 days after dosing ]
    Time of the maximum measured plasma concentration

  3. pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP [ Time Frame: on Day 3, 7, 10 and 14 ]
    Change in C reactive protein levels



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04524052    
Other Study ID Numbers: DWJ1516101_India
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No