NCT07156864View on ClinicalTrials.gov

"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients."

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
COVID-19
Interventions
DRUG

1/10 therapeutic dose

5 volunteers + 1 replacement volunteer will recieve 1/10 therapeutic dose of the study drug (parenteral administration).

DRUG

1/2 therapeutic dose

5 volunteers + 1 replacement volunteer will recieve 1/2 therapeutic dose of the study drug (parenteral administration).

DRUG

full therapeutic dose

15 volunteers + 3 replacement volunteers will recieve full therapeutic dose of the study drug (parenteral administration).

DRUG

Patients with a verified diagnosis of COVID-19

10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug (parenteral administration).

All Listed Sponsors
lead

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

OTHER