Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580236
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Study of the Drug B11-FC Botulism Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Safety Tolerability Immunogenicity Pharmacokinetics and Pharmacodynamics of the Drug B11-FC With a Single Application in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 110 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
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 110 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None