BotulismPhase 1/2NCT06580236
Study of the Drug B11-FC (Botulism Treatment)
A Phase 1/2 study testing B11-FC and Botulinum neurotoxin type A in people with Botulism, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial summary
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Botulism
- What is being tested?
- B11-FC and Botulinum neurotoxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 30 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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).
Show all 16Show fewer
- 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;
- Diagnosis of botulism
Who cannot join
- Volunteers cannot be included in the Phase 1 study if at least one of the following non-inclusion criteria is met:
- 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;
Show all 43Show fewer
- 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;
- Aggravated allergic history (history of anaphylactic shock, angioedema and other life-threatening conditions), hypersensitivity or allergic reactions to the administration of immunobiological drugs, exacerbation of allergic diseases on the day of inclusion in the study;
- History of severe infusion reactions
- Diabetes mellitus or other forms of impaired glucose tolerance;
- Previously diagnosed or currently suspected multiple sclerosis or other neuromuscular degenerative disease
- Previously diagnosed or currently suspected coagulopathies
- Previously diagnosed or currently suspected vasculitis
- A history of malignant neoplasms, with the exception of basal cell or squamous cell epithelial carcinomas of the skin, which were removed without signs of metastasis within 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 currently or in history;
- Alcohol consumption exceeding the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, drinking alcohol within 48 hours before administration of the study drug;
- Smoking: more than 10 cigarettes per 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 drug administration.
- The presence of a concomitant disease that may affect the assessment of the study results or which, 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's physician, may be a contraindication to participation in the study;
- The volunteer's weight is less than 45 and more than 100 kg (even if the volunteer's BMI corresponds to the norm - clause 8 of the inclusion criteria).
- Additional criteria for non-inclusion in stage 2
- Previously diagnosed or currently suspected motor neuron disease, peripheral neuropathy of the nerves of the lower extremities
- Current skin infection/skin problems at the injection site (foot)
- Scar tissue or tattooed skin over the extensor digitorum brevis muscles.
- Abnormal (based on the principal judgment of the investigator) results of a nerve conduction study (NCS)
- Any medical condition that may place the participant at risk of exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that may affect neuromuscular function
- Previous treatment with botulinum toxin (BoNT) (any serotype) within the last 6 months
- Known hypersensitivity to any of the components of the drug botulinum neurotoxin type A
- Use of agents that may affect neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymyxins, magnesium sulfate, anticholinesterases, succinylcholine and quinidine.
- Volunteers cannot be included in the Stage 3 study if at least one of the following non-inclusion criteria is met:
- Limitation of the legality of obtaining informed consent to participate in the study.
- Duration of illness more than 7 days
- Age under 18 years
- Pregnancy
About this study
Official title: Study of the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of the Drug B11-FC With a Single Application in Adults
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults
Read the detailed description
A three-staged, open-label, prospective study of B11-FC to examine safety, tolerability, immunogenicity, and pharmacokinetics in three dose-escalation groups; pharmacodynamics with a single dose in adult volunteers in a model of the effect of botulinum antitoxin on paralysis caused by botulinum neurotoxin A in EDB muscles in the framework of a double-blind, placebo-controlled comparative study and studying the effect of the study drug on the course of disease caused by botulinum toxin type A in adult patients diagnosed botulism.
The study plans to examine the safety of the drug after a single dose. The therapeutic dose is calculated based on the activity of monoclonal antibodies included in the drug. To ensure the safety of volunteers, drug administration will be started with 1/10 of the therapeutic dose.
The study for each participant of stages 1 and 2 consists of 3 periods:
- screening (no more than 7 days before drug administration);
- period of administration of the study drug and observation in a hospital setting (hospitalization for 7 days);
- follow-up period (from 8 to 90 days from the date of administration). A total of 9 visits will take place, including a screening visit, of which 1 visit will be carried out as part of inpatient observation, and 7 visits will be outpatient. During the visits, volunteers will be examined in accordance with the study plan.
The study design will be the same for all volunteers, with the exception of the dosing regimen.
The study for each participant of stage 3 consists of 3 periods:
- screening (on the day of hospitalization);
- period of administration of the study drug and observation in a hospital setting (hospitalization for at least 7 days);
- follow-up period (from the moment of discharge from the hospital to 90 days from the moment of administration).
During the visits, patients will be assessed and treated according to the study design and botulism treatment standards.
- Conditions
- Botulism
- Being tested
- B11-FC, Botulinum neurotoxin type A, Placebo
- Medical subject headings
- Botulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B11-FCDrug
Infusion
Botulinum neurotoxin type ADrug
Infusion
PlaceboOther
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - doze 1 | Experimental | B11-FC 0,06 mg/kg single infusion - 5 subjects Receives: Drug: B11-FC |
| Arm 2 - doze 2 | Experimental | B11-FC 0,3 mg/kg single infusion - 5 subjects Receives: Drug: B11-FC |
| Arm 3 - doze 3 | Experimental | B11-FC 0,6 mg/kg single infusion - 5 subjects Receives: Drug: B11-FC |
| Arm 4 - selected doze | Active comparator | B11-FC 0,6 mg/kg single infusion + botulinum neurotoxin - 5 subjects Receives: Drug: B11-FC; Drug: Botulinum neurotoxin type A |
| Arm 5 - placebo | Placebo comparator | Placebo + botulinum neurotoxin - 5 subjects Receives: 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 Receives: Drug: B11-FC |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate measurement
Measured: through study completion, an average of 1 year
respiratory rate
respiratory rate measurement
Measured: through study completion, an average of 1 year
blood pressure (both systolic and diastolic)
blood pressure measurement
Measured: through study completion, an average of 1 year
ECG Cardiac rate (beats per minute)
ECG Cardiac rate (beats per minute) measurement
Measured: through study completion, an average of 1 year
ECG RR Interval (ms)
ECG RR Interval (ms) measurement
Measured: through study completion, an average of 1 year
ECG PQ interval (ms)
ECG PQ interval (ms) measurement
Measured: through study completion, an average of 1 year
ECG QRS interval (ms)
ECG QRS interval (ms) measurement
Measured: through study completion, an average of 1 year
ECG QT interval (ms)
ECG QT interval (ms) measurement
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startAug 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BotulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580236
- Sponsor's protocol ID
- № 01- B11-FC -2024
- Status last verified
- Jul 2024
- First submitted
- 15 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of the Drug B11-FC With a Single Application in Adults
- ClinicalTrials.gov ID
- NCT06580236
- Acronym / sponsor ID
- № 01- B11-FC -2024
- Conditions
- Botulism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults
Detailed description
A three-staged, open-label, prospective study of B11-FC to examine safety, tolerability, immunogenicity, and pharmacokinetics in three dose-escalation groups; pharmacodynamics with a single dose in adult volunteers in a model of the effect of botulinum antitoxin on paralysis caused by botulinum neurotoxin A in EDB muscles in the framework of a double-blind, placebo-controlled comparative study and studying the effect of the study drug on the course of disease caused by botulinum toxin type A in adult patients diagnosed botulism.
The study plans to examine the safety of the drug after a single dose. The therapeutic dose is calculated based on the activity of monoclonal antibodies included in the drug. To ensure the safety of volunteers, drug administration will be started with 1/10 of the therapeutic dose.
The study for each participant of stages 1 and 2 consists of 3 periods:
- screening (no more than 7 days before drug administration);
- period of administration of the study drug and observation in a hospital setting (hospitalization for 7 days);
- follow-up period (from 8 to 90 days from the date of administration). A total of 9 visits will take place, including a screening visit, of which 1 visit will be carried out as part of inpatient observation, and 7 visits will be outpatient. During the visits, volunteers will be examined in accordance with the study plan.
The study design will be the same for all volunteers, with the exception of the dosing regimen.
The study for each participant of stage 3 consists of 3 periods:
- screening (on the day of hospitalization);
- period of administration of the study drug and observation in a hospital setting (hospitalization for at least 7 days);
- follow-up period (from the moment of discharge from the hospital to 90 days from the moment of administration).
During the visits, patients will be assessed and treated according to the study design and botulism treatment standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - doze 1 | Experimental | Drug: B11-FCB11-FC 0,06 mg/kg single infusion - 5 subjects |
| Arm 2 - doze 2 | Experimental | Drug: B11-FCB11-FC 0,3 mg/kg single infusion - 5 subjects |
| Arm 3 - doze 3 | Experimental | Drug: B11-FCB11-FC 0,6 mg/kg single infusion - 5 subjects |
| Arm 4 - selected doze | Active comparator | Drug: B11-FC, Drug: Botulinum neurotoxin type AB11-FC 0,6 mg/kg single infusion + botulinum neurotoxin - 5 subjects |
| Arm 5 - placebo | Placebo comparator | Drug: Botulinum neurotoxin type A, Other: PlaceboPlacebo + botulinum neurotoxin - 5 subjects |
| Arm 6 - selected doze - patients with confirmed botulism | Active comparator | Drug: B11-FCB11-FC 0,6 mg/kg single infusion - 10 subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (43 listed)
- Volunteers cannot be included in the Phase 1 study if at least one of the following non-inclusion criteria is met:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B11-FCInfusion | Drug | 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 AInfusion | Drug | Arm 4 - selected doze, Arm 5 - placebo |
| PlaceboInfusion | Other | Arm 5 - placebo |
Primary outcome
heart rate
Time frame: through study completion, an average of 1 year
heart rate measurement
respiratory rate
Time frame: through study completion, an average of 1 year
respiratory rate measurement
blood pressure (both systolic and diastolic)
Time frame: through study completion, an average of 1 year
blood pressure measurement
ECG Cardiac rate (beats per minute)
Time frame: through study completion, an average of 1 year
ECG Cardiac rate (beats per minute) measurement
ECG RR Interval (ms)
Time frame: through study completion, an average of 1 year
ECG RR Interval (ms) measurement
ECG PQ interval (ms)
Time frame: through study completion, an average of 1 year
ECG PQ interval (ms) measurement
ECG QRS interval (ms)
Time frame: through study completion, an average of 1 year
ECG QRS interval (ms) measurement
ECG QT interval (ms)
Time frame: through study completion, an average of 1 year
ECG QT interval (ms) measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Botulism
Enrolling by invitationPhase 4
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
Botulism
RecruitingPhase 3
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
Carpometacarpal Sprain, Thumb Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing B11-FC and Botulinum neurotoxin type A in people with Botulism, 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 16 inclusion and 43 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
heart rate (time frame: through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2024.