NCT06580236

Study of the Drug B11-FC (Botulism Treatment)

Study of the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of the Drug B11-FC With a Single Application in Adults

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Botulism

Interventions

Type	Name	Description
DRUG	B11-FC	Infusion
DRUG	Botulinum neurotoxin type A	Infusion
OTHER	Placebo	Infusion

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2024-08-30
• Last updated: 2024-08-30