An Open-label Study of the Safety and Pharmacokinetics of the TGKP
Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation