AzTrials
AzTrials

COVID-19Phase 1NCT07156864

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

A Phase 1 study testing 1/10 therapeutic dose, 1/2 therapeutic dose and full therapeutic dose in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
1/10 therapeutic dose, 1/2 therapeutic dose and full therapeutic dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Sep 2025to Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Stage 1
  • Each potential volunteer for inclusion in Stage 1 of the Study should meet all of the following 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.
Show all 33Show fewer
  • 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.
  • 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.
  • Stage 2
  • Each potential volunteer for inclusion in Stage 2 of the Study should meet all of the following criteria:
  • Written Informed Consent to participate in the study.
  • Men and women, age limits: min.: 18, max.: 45.
  • A positive test result for SARS-CoV-2 was obtained < 5 days before the inclusion in the Study, or clinical manifestations began, confirmed later by PCR/rapid test.
  • Oxygen saturation ≥93% without oxygen donation in any way, a diagnosis of COVID-19 is made, provided that symptoms appear no later than 5 days at the time of inclusion in the Study.
  • The presence of several (at least 2) symptoms of mild or moderate severity at the time of inclusion in the Study;
  • At the time of screening, the potential volunteer is not hospitalized due to the severity of the COVID-19 disease;
  • The presence of factors (at least 1) of a high risk of developing severe COVID-19 and / or hospitalization and / or death, according to the Investigator, not limited to the following:
  • patients not vaccinated against the current strain of the virus
  • elderly patients (over 60 years of age), including those with additional risk factors
  • obesity
  • patients with immunodeficiency, including those taking immunosuppressive drugs for any indication
  • comorbidities (diabetes mellitus, cardiovascular diseases, coagulopathies, chronic kidney disease, including conditions requiring dialysis, chronic lung diseases, liver diseases, etc.)
  • Consent to the use of effective methods of contraception during the entire period of participation in the Study.
  • The potential volunteer is able to perform visits during the Study.

Who cannot join

  • 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.
Show all 51Show fewer
  • 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.,).
  • Pregnancy or breast-feeding.
  • Systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg or higher than 90 mmHg; heart rate less than 60 beats / min or more than 100 beats / min.
  • A burdened allergic history (including, but not limited to, major multiform erythema, toxic epidermal necrolysis, angioedema, polymorphic exudative eczema, a history of serum sickness, hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the components of the drug, etc.).
  • History of severe infusion reactions
  • Diabetes mellitus or other forms of glucose tolerance disorders;
  • The medical history of malignant neoplasms, with the exception of basal cell or squamous cell epithelial skin carcinomas, which were removed without any signs of metastasis for 3 years.
  • Blood donation (450 ml or more of blood or plasma) less than 2 months before the start of the Study;
  • Taking narcotic and psychostimulant drugs at the present time or according to the anamnesis.
  • Drinking alcohol above the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the study drug administration.
  • Smoking: more than 10 cigarettes a day.
  • Planned hospitalization and / or surgical intervention during the period of participation in the Study, as well as 4 weeks before the expected date of study drug administration.
  • The presence of a concomitant disease that may affect the evaluation of the Study results or that, in the opinion of the Investigator, will not allow the volunteer to participate in the Study or may affect the conduct of the study and/or its results (including the assessment of safety parameters), any conditions that, in the opinion of the Investigator (doctor), may be a contraindication to participation in the Study.
  • The weight of a potential volunteer is less than 45 and more than 100 kg (even if the BMI of the volunteer corresponds to the norm-item 8 of the inclusion criteria).
  • Stage 2
  • The potential volunteer will not be included in Stage 2 of the Study in the following cases:
  • Inability to read in Russian; inability or unwillingness to understand the essence of the research. Any other conditions that limit the validity of obtaining informed consent or may affect the patient's ability to participate in the Study.
  • Pregnancy and lactation.
  • Severe and extremely severe course of COVID-19:
  • Blood oxygen saturation at rest according to pulse oximetry (SpO2) < 93% OR
  • PaO2 / FiO2 ≤ 300 mmHg OR
  • Respiratory failure and the need for invasive mechanical ventilation (with tracheal intubation) or ECMO; OR
  • Septic shock OR
  • Multiple organ failure
  • Previous plasma therapy from a recovered patient with COVID-19 or other mAb drugs against SARS CoV-2 for the treatment of COVID-19 disease that is ongoing at the time of inclusion in the Study.
  • The patient is currently hospitalized or, according to the Investigator, may require hospitalization in the next 24 hours due to the severity of the infection.
  • Oxygen therapy is required due to COVID-19 disease or an increase in the baseline oxygen flow rate due to COVID-19 disease is required in individuals on chronic oxygen therapy due to a non-COVID-19 comorbidity.
  • Confirmed active tuberculosis, AIDS (according to medical history, registration).
  • The presence of any life-threatening concomitant disease in a state of decompensation, which, in the opinion of the Investigator, makes the patient unsuitable for inclusion in the Study;
  • Body weight less than 40 kg.
  • Participation in any other study within the last 90 days.
  • Artificial lung ventilation is required or an unavoidable need for mechanical ventilation is predicted in the next 24 hours based on the patient's current condition.
  • A suspected or proven serious active bacterial, fungal, viral, or other infection (other than COVID-19) that the Investigator believes may pose a risk to the patient and affect the assessment of Study endpoints.
  • There are concomitant diseases that require surgical intervention within the next month.
  • A burdened allergic history (including, but not limited to, erythema majora multiforme, toxic epidermal necrolysis, angioedema, polymorphic exudative eczema, a history of serum sickness, hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the components of the study drug, etc.).
  • A history of severe infusion reactions.
  • Alcohol or drug addiction.

About this study

Official title: "Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC - Study Drug for Early Etiotropic Therapy of Coronavirus Infection Caused by the SARS-CoV-2 Virus, Using Heavy-chain Humanized Monoclonal Antibodies, After Single Administration to Adult Patients".

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
Being tested
1/10 therapeutic dose, 1/2 therapeutic dose, full therapeutic dose, Patients with a verified diagnosis of COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1/10 therapeutic doseDrug

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

  • 1/2 therapeutic doseDrug

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

  • full therapeutic doseDrug

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

  • Patients with a verified diagnosis of COVID-19Drug

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

Study groups in NCT07156864
Study groupRoleWhat they receive
1/10 therapeutic doseExperimental5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/10 therapeutic dose of the study drug.
Receives: Drug: 1/10 therapeutic dose
1/2 therapeutic doseExperimental5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/2 therapeutic dose of the study drug.
Receives: Drug: 1/2 therapeutic dose
full therapeutic doseExperimental15 healthy volunteers + 3 healthy replacement volunteers will recieve full therapeutic dose of the study drug.
Receives: Drug: Patients with a verified diagnosis of COVID-19
Patients with a verified diagnosis of COVID-19Experimental10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug.
Receives: Drug: full therapeutic dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of adverse events (AE)

    Measured: within 28 days after administration of the study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07156864
Sponsor's protocol ID
01-B5/В10-FC-2025
Status last verified
Sep 2025
First submitted
26 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1/10 therapeutic dose, 1/2 therapeutic dose and full therapeutic dose in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of adverse events (AE) (time frame: within 28 days after administration of the study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07156864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in