70
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
¼ of the full (target) dose (solution, 5 ml)
"1. st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration).~2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug (parenteral administration)."
½ of the full (target) dose (solution, 10 ml)
"1. st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration).~2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug (parenteral administration)."
full dose (solution, 20 ml)
"1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration).~2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug (parenteral administration)."
1 ½ of the full (target) dose (solution, 30 ml)
"1. st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration).~2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug (parenteral administration)."
2 full doses (solution, 40 ml)
"1. st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration).~2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) dose of the study drug (parenteral administration)."
course administration of the selected dose
10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo.
Placebo
1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration)
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
OTHER