The purpose of the trial is to study the tolerability, safety and pharmacokinetics of the study drug with participation of healthy volunteers after single intravenous administration with dose escalation (0.03 mg/kg, 0.06 mg/kg and 0.12 mg/kg). Before administration the study drug will be dosed and diluted in 200 ml of isotonic solution of 0.9% sodium chloride, and then will be administered once intravenously via infusion. During the entire follow-up period, the effect of the study drug on vital signs, instrumental and laboratory data, the development, severity and association of adverse events with the study drug will be monitored, investigated and studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A total of 25 volunteers will be randomized and receive the study drug, of which 5 - will receive ¼ therapeutic dose, 5 - will receive ½ therapeutic dose, 15 - will receive the full therapeutic dose.
Occurrence of AE
Occurrence of adverse events (AE)
Time frame: Within 28 days after administration of the drug
Occurrence of SAEs
Occurrence of serious adverse events (SAEs)
Time frame: Within 28 days after administration of the drug
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