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Clinical Trials/NCT04749173
NCT04749173
Completed
Phase 1

A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers

Daewoong Pharmaceutical Co. LTD.1 site in 1 country24 target enrollmentNovember 21, 2020
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ConditionsCovid19
InterventionsDWRX2003, 96mgDWRX2003, 432mgDWRX2003, 144mg
DrugsDWRX2003, 96mgDWRX2003, 432mgDWRX2003, 144mg

Overview

Phase
Phase 1
Intervention
DWRX2003, 96mg
Conditions
Covid19
Sponsor
Daewoong Pharmaceutical Co. LTD.
Enrollment
24
Locations
1
Primary Endpoint
Incidence of Treatment-Emergent Adverse Events
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This Phase I study is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability and PK profile of single intramuscular doses of DWRX2003 in healthy volunteers.

Registry
clinicaltrials.gov
Start Date
November 21, 2020
End Date
June 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy adults aged 19 or older and 55 or younger at the time of screening test
  • •A person who weighs 55.0 kg or more and whose BMI (body mass index) is above 18.0 and below 29.9;
  • •A person who has listened to the detailed explanation of this clinical trial and fully understood, decided to participate voluntarily, and agreed in writing before the screening procedure.
  • •A person who is eligible for this test when determining the person in charge of the test (or co-researcher who has been commissioned) due to physical examination, clinical laboratory examination, or examination.
  • •A person who has been tested negative for Corona-19 virus (COVID-19) infection conducted during a screening visit.
  • •A person who has agreed to use medically acceptable contraception during the pre-clinical trial period;

Exclusion Criteria

  • •A person with a history or medical condition that includes one or more of the following diseases:
  • •A person who is hypersensitive or has an history of overreaction to a clinical trial medication (or a component of a clinical trial medication) or emergency medication (epinephrine, dexamethasone, etc.)
  • •hepatitis B (active hepatitis B or carrier), hepatitis C, human immunodeficiency virus (HIV), or syphilis infection (unless fully cured in case of hepatitis B virus history)
  • •A person who is deemed clinically significant in determining the test manager (or a joint researcher) for the past or present history of asthma, rash, vascular edema, eczema, etc.
  • •A person who has clinical significance, liver, kidney, nervous system, respiratory system, endocrine system, blood, tumor, cardiovascular, urinary system, mental system disease, or history
  • •A person who has a history of malignant tumors in the past or present
  • •A person who has a history of whole-body anti-infection that has been terminated within 28 days prior to the administration of clinical trial medication, or a history of systemic or local infection that requires hospitalization or intravenous administration within 6 months before clinical trial medication is administered.
  • •A person who has undergone surgical intervention or surgery within 28 days prior to the administration of a clinical trial medication or is scheduled to undergo surgical procedures during the clinical trial period.
  • •A person who has a clinically significant blood clotting disorder or tendency to hemorrhagic
  • •A person who shows the following results in a screening test:

Arms & Interventions

Cohort 1 (96 mg)

- Ventrogluteal area: 48 mg/0.2 mL x 2 sites

Intervention: DWRX2003, 96mg

Cohort 2 (432 mg)

* Deltoid area: 72 mg/0.3 mL x 2 sites * Ventrogluteal area: 144 mg/0.6 mL x 2 sites

Intervention: DWRX2003, 432mg

Cohort A (144 mg)

- Deltoid area: 72 mg/0.3 mL x 2 sites

Intervention: DWRX2003, 144mg

Cohort B (144 mg)

- Ventrogluteal area: 72 mg/0.3 mL x 2 sites

Intervention: DWRX2003, 144mg

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time Frame: follow-up 42 days after dosing

Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) \[ Time Frame: follow-up 42 days after dosing \]

Study Sites (1)

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