Covid19Phase 1NCT04749173
To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.
A Phase 1 study testing DWRX2003, 96mg, DWRX2003, 432mg and DWRX2003, 144mg in people with Covid19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- DWRX2003, 96mg, DWRX2003, 432mg and DWRX2003, 144mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2020to 18 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Covid19
- Being tested
- DWRX2003, 96mg, DWRX2003, 432mg, DWRX2003, 144mg
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWRX2003, 96mgDrug
Drug: Placebo Intramuscularly injection at predefined injection sites
DWRX2003, 432mgDrug
Drug: Placebo Intramuscularly injection at predefined injection sites
DWRX2003, 144mgDrug
Drug: Placebo Intramuscularly injection at predefined injection sites
DWRX2003, 144mgDrug
Drug: Placebo Intramuscularly injection at predefined injection sites
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (96 mg) | Experimental | - Ventrogluteal area: 48 mg/0.2 mL x 2 sites Receives: Drug: DWRX2003, 96mg |
| Cohort 2 (432 mg) | Experimental | * Deltoid area: 72 mg/0.3 mL x 2 sites
* Ventrogluteal area: 144 mg/0.6 mL x 2 sites Receives: Drug: DWRX2003, 432mg |
| Cohort A (144 mg) | Experimental | - Deltoid area: 72 mg/0.3 mL x 2 sites Receives: Drug: DWRX2003, 144mg |
| Cohort B (144 mg) | Experimental | - Ventrogluteal area: 72 mg/0.3 mL x 2 sites Receives: Drug: DWRX2003, 144mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ]
Measured: follow-up 42 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start21 Nov 2020
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749173
- Sponsor's protocol ID
- DW_DWJ1516101
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04749173
- Acronym / sponsor ID
- DW_DWJ1516101
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (96 mg) | Experimental | Drug: DWRX2003, 96mg- Ventrogluteal area: 48 mg/0.2 mL x 2 sites |
| Cohort 2 (432 mg) | Experimental | Drug: DWRX2003, 432mg* Deltoid area: 72 mg/0.3 mL x 2 sites * Ventrogluteal area: 144 mg/0.6 mL x 2 sites |
| Cohort A (144 mg) | Experimental | Drug: DWRX2003, 144mg- Deltoid area: 72 mg/0.3 mL x 2 sites |
| Cohort B (144 mg) | Experimental | Drug: DWRX2003, 144mg- Ventrogluteal area: 72 mg/0.3 mL x 2 sites |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- A person with a history or medical condition that includes one or more of the following diseases:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWRX2003, 96mgDrug: Placebo Intramuscularly injection at predefined injection sites | Drug | Cohort 1 (96 mg) |
| DWRX2003, 432mgDrug: Placebo Intramuscularly injection at predefined injection sites | Drug | Cohort 2 (432 mg) |
| DWRX2003, 144mgDrug: Placebo Intramuscularly injection at predefined injection sites | Drug | Cohort A (144 mg) |
| DWRX2003, 144mgDrug: Placebo Intramuscularly injection at predefined injection sites | Drug | Cohort B (144 mg) |
Primary outcome
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 ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWRX2003, 96mg, DWRX2003, 432mg and DWRX2003, 144mg in people with Covid19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: follow-up 42 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.