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 range18 Years – 45 Years

SexALL

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;
✓. 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;

What they're measuring

heart rate

Timeframe: through study completion, an average of 1 year

respiratory rate

Timeframe: through study completion, an average of 1 year

blood pressure (both systolic and diastolic)

Timeframe: through study completion, an average of 1 year

ECG Cardiac rate (beats per minute)

Timeframe: through study completion, an average of 1 year

ECG RR Interval (ms)

Timeframe: through study completion, an average of 1 year

ECG PQ interval (ms)

Timeframe: through study completion, an average of 1 year

ECG QRS interval (ms)

Timeframe: through study completion, an average of 1 year

ECG QT interval (ms)

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06580236

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More Botulism trials

Who can participate

Age range18 Years – 45 Years

SexALL

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;
✓. 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;

What they're measuring

heart rate

Timeframe: through study completion, an average of 1 year

respiratory rate

Timeframe: through study completion, an average of 1 year

blood pressure (both systolic and diastolic)

Timeframe: through study completion, an average of 1 year

ECG Cardiac rate (beats per minute)

Timeframe: through study completion, an average of 1 year

ECG RR Interval (ms)

Timeframe: through study completion, an average of 1 year

ECG PQ interval (ms)

Timeframe: through study completion, an average of 1 year

ECG QRS interval (ms)

Timeframe: through study completion, an average of 1 year

ECG QT interval (ms)

Timeframe: through study completion, an average of 1 year