Status and phase
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Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
A volunteer may terminate his participation in the study at any stage of its implementation. The principal investigator may remove a volunteer from the study at any time in the following cases:
Primary purpose
Allocation
Interventional model
Masking
25 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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