Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05440643
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2022-06-17
Brief Title:
Peanut Sublingual Immunotherapy SLIT-Tablet for Treatment of Peanut Allergy
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Phase I Open-label Trial to Assess the Tolerability and Safety of an Up-dosing Regimen With a Once-daily Peanut SLIT-tablet in Adults Adolescents and Children With Peanut Allergy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet
Detailed Description:
This is a phase I open-label dose-escalation multi-site trial including subjects with peanut allergy confirmed by screening double-blind placebo-controlled food challenge The trial is conducted in 2 parts part 1 will determine the entry dose of the up-dosing regimen UDR in adults and adolescents and part 2 will characterize the tolerability of the up-dosing regimen in adults adolescents and children
Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study
In part 1 subjects will receive a peanut SLIT-tablet with one of five increasing doses once daily for 2 weeks
In part 2 subjects will receive a series of increasing doses of the peanut SLIT-tablet where each dose is taken once daily for 2 weeks The entry dose for the up dosing regimen will be determined from part 1
The trial will consist of up to 10 cohorts part 1 is cohort 1-5 part 2 is cohort 6-10
Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study
In part 1 subjects will receive a peanut SLIT-tablet with one of five increasing doses once daily for 2 weeks
In part 2 subjects will receive a series of increasing doses of the peanut SLIT-tablet where each dose is taken once daily for 2 weeks The entry dose for the up dosing regimen will be determined from part 1
The trial will consist of up to 10 cohorts part 1 is cohort 1-5 part 2 is cohort 6-10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None