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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (96 mg) | Experimental | - Ventrogluteal area: 48 mg/0.2 mL x 2 sites |
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| Cohort 2 (432 mg) | Experimental |
|
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| Cohort A (144 mg) | Experimental | - Deltoid area: 72 mg/0.3 mL x 2 sites |
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| Cohort B (144 mg) | Experimental | - Ventrogluteal area: 72 mg/0.3 mL x 2 sites |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWRX2003, 96mg | Drug | Drug: Placebo Intramuscularly injection at predefined injection sites |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National university hospital | Daejeon | South Korea |
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| DWRX2003, 432mg | Drug | Drug: Placebo Intramuscularly injection at predefined injection sites |
|
| DWRX2003, 144mg | Drug | Drug: Placebo Intramuscularly injection at predefined injection sites |
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| DWRX2003, 144mg | Drug | Drug: Placebo Intramuscularly injection at predefined injection sites |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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