To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: DWRX2003, 96mg; Drug: DWRX2003, 432mg; Drug: DWRX2003, 144mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged 19 or older and 55 or younger at the time of screening test
2. A person who weighs 55.0 kg or more and whose BMI (body mass index) is above 18.0 and below 29.9;
3. 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.
4. 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.
5. A person who has been tested negative for Corona-19 virus (COVID-19) infection conducted during a screening visit.
6. A person who has agreed to use medically acceptable contraception during the pre-clinical trial period;

Exclusion Criteria:

1. A person with a history or medical condition that includes one or more of the following diseases:

   1. 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.)
   2. 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)
   3. 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.
   4. A person who has clinical significance, liver, kidney, nervous system, respiratory system, endocrine system, blood, tumor, cardiovascular, urinary system, mental system disease, or history
   5. A person who has a history of malignant tumors in the past or present
   6. 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.
   7. 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.
   8. A person who has a clinically significant blood clotting disorder or tendency to hemorrhagic

2. A person who shows the following results in a screening test:

   fi A person whose blood level of AST (SGOT) and ALT (SGPT) exceeds twice the upper limit of the reference range fi A person whose blood treatment line level exceeds the upper limit of the reference range or whose eGFR calculated by the Modification of Diet in Rental Disase (MDR) formula is less than 90ml/min/1.73㎡ fi A person who has been found to be abnormal in the 12-lead ECG test fi In the vital signs measured at the left position after a rest for more than three minutes, a person who showed a figure equivalent to systolic blood pressure of "90 mmHg or > 150 mmHg or extended blood pressure of "60 mmHg or >100 mmHg." fi A person who has tested positive for serum (RPR Ab, anti-HIV (AIDS), HBs Ag, HCV Ab) fi A person whose C-reactive protein (CRP) level is 1.5 times higher than the upper limit of the reference range.

   fi In addition, a person who showed the results of a decision that the test manager (or a commissioned joint researcher) is clinically significant;

3. A person who has a history of drug abuse or has tested positive for abuse in urine drug testing
4. A person who participated in other clinical trials (including biological equivalence tests) within six months prior to the administration of the clinical trial medication (one test subject cannot participate in another cohort)
5. A person who has given full blood or blood donation within two months or within one month before the administration of a clinical trial medication or received blood transfusion within one month before the administration of a clinical trial medication.
6. A person who drinks continuously (21 units/week, 1 unit = 10 g of pure alcohol) within three months prior to administration of clinical trial medication, or cannot drink alcohol during hospitalization.
7. A person who smokes more than 10 cigarettes a day within one month prior to the administration of a clinical trial medication or who is not allowed to smoke during the hospitalization period.
8. A person who is not prohibited from eating anything other than food provided by the clinical testing institution during his/her admission period;
9. A male person who has a child plan or plans to donate sperm during the period prior to the clinical trial, or a female person who has a plan to conceive or breast-feed.
10. In addition to the above criteria, a person deemed inappropriate for the participation of a clinical trial by the person in charge of testing (or a joint researcher who has been delegated)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1 (96 mg); - Ventrogluteal area: 48 mg/0.2 mL x 2 sites	Drug: DWRX2003, 96mg; Drug: Placebo Intramuscularly injection at predefined injection sites
EXPERIMENTAL: Cohort 2 (432 mg); Deltoid area: 72 mg/0.3 mL x 2 sites; Ventrogluteal area: 144 mg/0.6 mL x 2 sites	Drug: DWRX2003, 432mg; Drug: Placebo Intramuscularly injection at predefined injection sites
EXPERIMENTAL: Cohort A (144 mg); - Deltoid area: 72 mg/0.3 mL x 2 sites	Drug: DWRX2003, 144mg; Drug: Placebo Intramuscularly injection at predefined injection sites
EXPERIMENTAL: Cohort B (144 mg); - Ventrogluteal area: 72 mg/0.3 mL x 2 sites	Drug: DWRX2003, 144mg; Drug: Placebo Intramuscularly injection at predefined injection sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: follow-up 42 days after dosing ]	follow-up 42 days after dosing

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2020
• Primary Completion (ACTUAL): June 18, 2021
• Study Completion (ACTUAL): June 18, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (ACTUAL): February 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DW_DWJ1516101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No