Study of the Drug B11-FC (Botulism Treatment)

NCT06580236 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: № 01- B11-FC -2024
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults

Conditions

Botulism

Outcome Measures

Primary Outcomes (8)

• heart rate

  heart rate measurement

  through study completion, an average of 1 year

• respiratory rate

  respiratory rate measurement

  through study completion, an average of 1 year

• blood pressure (both systolic and diastolic)

  blood pressure measurement

  through study completion, an average of 1 year

• ECG Cardiac rate (beats per minute)

  ECG Cardiac rate (beats per minute) measurement

  through study completion, an average of 1 year

• ECG RR Interval (ms)

  ECG RR Interval (ms) measurement

  through study completion, an average of 1 year

• ECG PQ interval (ms)

  ECG PQ interval (ms) measurement

  through study completion, an average of 1 year

• ECG QRS interval (ms)

  ECG QRS interval (ms) measurement

  through study completion, an average of 1 year

• ECG QT interval (ms)

  ECG QT interval (ms) measurement

  through study completion, an average of 1 year

Study Arms (6)

Arm 1 - doze 1

EXPERIMENTAL

B11-FC 0,06 mg/kg single infusion - 5 subjects

Drug: B11-FC

Arm 2 - doze 2

EXPERIMENTAL

B11-FC 0,3 mg/kg single infusion - 5 subjects

Drug: B11-FC

Arm 3 - doze 3

EXPERIMENTAL

B11-FC 0,6 mg/kg single infusion - 5 subjects

Drug: B11-FC

Arm 4 - selected doze

ACTIVE COMPARATOR

B11-FC 0,6 mg/kg single infusion + botulinum neurotoxin - 5 subjects

Drug: B11-FC; Drug: Botulinum neurotoxin type A

Arm 5 - placebo

PLACEBO COMPARATOR

Placebo + botulinum neurotoxin - 5 subjects

Drug: Botulinum neurotoxin type A; Other: Placebo

Arm 6 - selected doze - patients with confirmed botulism

ACTIVE COMPARATOR

B11-FC 0,6 mg/kg single infusion - 10 subjects

Drug: B11-FC

Interventions

B11-FC DRUG

Infusion

Arm 1 - doze 1; Arm 2 - doze 2; Arm 3 - doze 3; Arm 4 - selected doze; Arm 6 - selected doze - patients with confirmed botulism

Botulinum neurotoxin type A DRUG

Infusion

Arm 4 - selected doze; Arm 5 - placebo

Placebo OTHER

Infusion

Arm 5 - placebo

Eligibility Criteria

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

You may qualify if:

• Volunteers who meet all the specified criteria will be included in the study of stages 1 and 2:
• 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;
• Negative alcohol test;
• Indicators of general and biochemical blood tests during screening are within the range of 1.1 X VGRI - 0.9 X NGRI,
• Immunoglobulin E levels are not higher than 2 X VGRI
• The Stage 3 study will include patients who meet all of the following criteria:
• Patients of both sexes over 18 years old
• 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;

You may not qualify if:

• 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;
• Administration of monoclonal antibodies, immunoglobulins or blood products in the last 3 months;
• History of autoimmune diseases or systemic collagenosis requiring immunosuppressive therapy.
• Volunteers who have undergone an organ transplant, including bone marrow or peripheral blood stem cell (PBSC) transplantation.
• Taking immunosuppressive drugs and/or immunomodulators within 6 months before the start of the study;
• Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], etc.)
• Systolic blood pressure less than 100 mmHg or above 130 mmHg; diastolic blood pressure less than 60 mmHg or above 90 mmHg; heart rate less than 60 beats/min or more than 90 beats/min;
• History of severe infusion reactions

Sponsors & Collaborators

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

MeSH Terms

Conditions

Botulism

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuromuscular Junction Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurotoxicity Syndromes; Foodborne Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

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 15, 2024
• First Posted: August 30, 2024
• Study Start: August 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share