Study of the Drug B11-FC (Botulism Treatment) (NCT06580236) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of the Drug B11-FC (Botulism Treatment)
40 participantsStarted 2024-08
Plain-language summary
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy volunteers of both sexes aged 18 to 45 years (inclusive);
. Provided signed Informed Consent prior to the initiation of any screening procedures, and the ability, in the opinion of the Investigator, to comply with all study requirements;
. Body mass index (BMI) 18.5 - 29.9 kg/m2 inclusive;
. Healthy according to the results of a medical examination: no history, as well as according to a screening examination, of pathologies of the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which may affect the safety of the volunteer and the evaluation of the study results (clinical, instrumental and laboratory studies did not reveal diseases or deviations from reference values, including: hemodynamic parameters within normal limits: systolic blood pressure (BP) within 100-130 mmHg, diastolic blood pressure within 60-90 mmHg, heart rate - 60-90 beats/min, respiratory rate - 14-20 per minute, body temperature - 35.9-36.9°C; no deviations from the norm in the results of laboratory and instrumental examinations, including ECG).
. Consent to use effective methods of contraception during the entire period of participation in the study (dual barrier method: male or female condom and combined hormonal contraceptive (oral, vaginal and transdermal forms can be used), or use of a condom or diaphragm with spermicide throughout the study period).
. Negative pregnancy test based on urine test results at the screening visit (for women of reproductive age)
. Negative tests for HIV, hepatitis B and C, syphilis;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
heart rate
Timeframe: through study completion, an average of 1 year
2
respiratory rate
Timeframe: through study completion, an average of 1 year
3
blood pressure (both systolic and diastolic)
Timeframe: through study completion, an average of 1 year
4
ECG Cardiac rate (beats per minute)
Timeframe: through study completion, an average of 1 year
5
ECG RR Interval (ms)
Timeframe: through study completion, an average of 1 year
6
ECG PQ interval (ms)
Timeframe: through study completion, an average of 1 year
7
ECG QRS interval (ms)
Timeframe: through study completion, an average of 1 year
8
Trial details
NCT IDNCT06580236
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
. Negative test for the presence of narcotic and psychostimulant drugs in the urine;
Exclusion criteria
. Inability to read Russian; inability or unwillingness to understand the essence of the study. Any other condition that limits the eligibility of obtaining informed consent or may affect the volunteer's ability to participate in the study;
. History of botulism, repeated administration of high doses of botulinum neurotoxin type A for cosmetic or therapeutic purposes
. Acute infectious diseases within 2 weeks and non-infectious diseases, exacerbations of chronic diseases within 4 weeks preceding screening;
. The presence of changes in the myocardium of an inflammatory or dystrophic nature according to the results of an ECG during screening;
. Volunteer participation in any other clinical trial within the last 90 days;
. History of splenectomy.
. Presence of mental illness (registered with a psychiatrist).
. Treatment with steroids (excluding hormonal contraceptives) in the last 10 days;
ECG QT interval (ms)
Timeframe: through study completion, an average of 1 year