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

NCT07156864 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 01-B5/В10-FC-2025
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events (AE)

  within 28 days after administration of the study drug

Study Arms (4)

1/10 therapeutic dose

EXPERIMENTAL

5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/10 therapeutic dose of the study drug.

Drug: 1/10 therapeutic dose

1/2 therapeutic dose

EXPERIMENTAL

5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/2 therapeutic dose of the study drug.

Drug: 1/2 therapeutic dose

full therapeutic dose

EXPERIMENTAL

15 healthy volunteers + 3 healthy replacement volunteers will recieve full therapeutic dose of the study drug.

Drug: Patients with a verified diagnosis of COVID-19

Patients with a verified diagnosis of COVID-19

EXPERIMENTAL

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

Drug: full therapeutic dose

Interventions

1/10 therapeutic dose DRUG

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

1/10 therapeutic dose

1/2 therapeutic dose DRUG

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

1/2 therapeutic dose

full therapeutic dose DRUG

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

Patients with a verified diagnosis of COVID-19

Patients with a verified diagnosis of COVID-19 DRUG

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

full therapeutic dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Stage 1
• 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.
• 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.
• Body mass index (BMI) is 18.5≤BMI≤30.
• A negative pregnancy test result based on the results of a urine test (for women of childbearing age).
• Negative test results for HIV, hepatitis B and C, syphilis.
• A negative urine test result for presence of narcotic and psychostimulants.
• A negative alcohol content test.
• Indicators of general and biochemical blood analysis at screening in the range of 1.1 X VGRI - 0.9 X NGRI.
• Indicators of immunoglobulin E are not higher than 2 X IGRI.

You may not qualify if:

• Stage 1
• The potential volunteer will not be included in Stage 1 of the Study in the following cases:
• 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.
• Plasma treatment from a recovered COVID-19 patient or MCA against SARS-CoV-2 in the last 3 months.
• Acute infectious diseases within 2 weeks and non-infectious diseases, exacerbations of chronic diseases within 4 weeks before the screening.
• The presence of inflammatory or dystrophic changes in the myocardium according to the results of ECG performed on the screening.
• The volunteer's participation in any other study within the last 90 days.
• A history of splenectomy.
• Presence of mental illnesses (registered by psychiatric / mental health facility).
• Treatment with steroids (excluding hormonal contraceptives) for the last 10 days.
• Administration of monoclonal antibodies, immunoglobulins or blood products in the last 3 months.
• Autoimmune diseases or a history of systemic collagenosis that require immunosuppressive therapy.
• Volunteers who have undergone organ transplants, including bone marrow or peripheral blood stem cell (PSCC) transplants.
• Immunosuppressive drugs and / or immunomodulators intake for 6 months prior to the start of the Study.
• Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], etc.,).

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share