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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Completed

CT.gov ID

NCT04749173

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: DWRX2003, 96mg Drug: DWRX2003, 432mg Drug: DWRX2003, 144mg Drug: DWRX2003, 144mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2020

Actual Primary Completion Date :

Jun 18, 2021

Actual Study Completion Date :

Jun 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [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 ]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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;

A person who has a history of drug abuse or has tested positive for abuse in urine drug testing
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)
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.
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.
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.
A person who is not prohibited from eating anything other than food provided by the clinical testing institution during his/her admission period;
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.
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National university hospital	Daejeon		Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04749173

Other Study ID Numbers:

DW_DWJ1516101

First Posted:

Feb 11, 2021

Last Update Posted:

Dec 13, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 13, 2021