This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Intramuscularly injection at predefined injection sites Drug: Placebo Intramuscularly injection at predefined injection sites
Incidence of Treatment-Emergent Adverse Events
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Time frame: follow-up 35 days after dosing
To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax
Measured through Maximum (peak) plasma drug concentration (Cmax)
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through tmax
Time to reach Cmax following IP administration (tmax)
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last
Area under the curve from zero to time of last measurable concentration (AUC0-last)
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞
Area under the curve from zero to infinity (AUC0-∞)
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2
Elimination half-life (t1/2)
Time frame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
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