Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-29
Brief Title:
A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
Sponsor:
AmtixBio Co Ltd
Organization:
AmtixBio Co Ltd
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The study is designed to evaluate the Safety Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Detailed Description:
This Phase 2 multicenter randomized double-blind placebo-controlled study is designed to assess the efficacy safety and tolerability of ATB1651 when administered topically to the great hallux toenail of participants with mild to moderate onychomycosis who are otherwise healthy
This study will enroll upto 120 participants in 31 optional sequential cohorts
Participants in Cohorts 1 to 3 will be randomized within each cohort to receive either ATB1651 3 or placebo at a ratio of 51
An optional cohort Cohort 4 may enroll up to 30 participants who will be randomized to receive either ATB1651 5 or placebo at a ratio of 51
Dosing will start with Cohort 1 followed at least 4 weeks later by Cohort 2 The decision to continue dosing in Cohort 2 beyond 12 weeks andor to commence Cohort 3 at the planned dosage regimen or a modified dosage regimen will be determined by the Safety Review Committee SRC
This study will enroll upto 120 participants in 31 optional sequential cohorts
Participants in Cohorts 1 to 3 will be randomized within each cohort to receive either ATB1651 3 or placebo at a ratio of 51
An optional cohort Cohort 4 may enroll up to 30 participants who will be randomized to receive either ATB1651 5 or placebo at a ratio of 51
Dosing will start with Cohort 1 followed at least 4 weeks later by Cohort 2 The decision to continue dosing in Cohort 2 beyond 12 weeks andor to commence Cohort 3 at the planned dosage regimen or a modified dosage regimen will be determined by the Safety Review Committee SRC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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