Chungnam National university hospital
Daejeon, South Korea
NCT Number: NCT04749173
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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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Daejeon, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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;
Drug: Placebo Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
Drug: Placebo Intramuscularly injection at predefined injection sites
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 ]
Daewoong Pharmaceutical Co. LTD.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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