"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the… (NCT07156864) | Clinical Trial Compass
Not Yet RecruitingPhase 1
"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".
35 participantsStarted 2025-09
Plain-language summary
A two-stage open-label, prospective, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity study with participation of healthy volunteers in three dose-escalation groups and patients with a confirmed diagnosis of COVID-19.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Written Informed Consent to participate in the Study.
✓. Men and women, age limits: min.: 18, max.: 45.
✓. Healthy according to the results of a medical examination: no history of pathology in the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, or blood, which may affect the safety of the volunteer and the assessment of the Study results (no diseases or clinically significant abnormalities were revealed by clinical, instrumental, and laboratory tests).
✓. Negative test result for COVID-19, determined by PCR at the screening.
✓. No contact with COVID-19 patients for at least 14 days prior to inclusion in the Study (according to information provided by potential volunteer).
✓. Negative test result for presence of IgM antibodies to SARS CoV2 by enzyme-linked immunosorbent assay.
✓. The result of IgG to S-protein or RBD of no more than x3 IGRI (or no more than 30 BAU) to SARS CoV2 by enzyme-linked immunosorbent assay, regardless of the previous immune status.
✓. Consent to the use effective methods of contraception during the entire period of participation in the Study.
Exclusion criteria
✕. Inability to read in Russian; inability or unwillingness to understand the essence of the Study. Any other condition that restricts the validity of obtaining informed consent or may affect the volunteer's ability to participate in the Study.
What they're measuring
1
Occurrence of adverse events (AE)
Timeframe: within 28 days after administration of the study drug
Trial details
NCT IDNCT07156864
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation