To investigate the safety/tolerability and pharmacokinetic characteristics after single intravenous (IV) administration of hzVSF-v13 (humanized Virus Suppressing Factor-variant 13) in healthy male volunteers
Dose blocked-randomized, double-blind, placebo controlled, single dose, dose-escalation study to investigate the safety/tolerability and pharmacokinetic characteristics of hzVSF-v13 after IV administration in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Seoul National University Hospital
Seoul, South Korea
Safety and Tolerability Assessments by Vital Signs
Systolic Blood Pressure: ≤ 90 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 140 mmHg and increase from baseline ≥ 20 mmHg Diastolic Blood Pressure: ≤ 50 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 90 mmHg and increase from baseline ≥ 10 mmHg Heart Rate: ≤ 40 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 100 beats/min and increase from baseline ≥ 20 beats/min
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
Pharmacokinetic Characteristics - Cmax (Concentration Maximum)
Maximum observed Concentration of hzVSF-v13 from Day1 to Day92.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
PK - AUClast (Area Under the Curve Last)
Area under the plasma concentration from Day1 to time of last measurable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
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