Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT06327295
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 3+1 (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 5:1.
* 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 5:1.
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 and/or to commence Cohort 3, at the planned dosage regimen or a modified dosage regimen, will be determined by the Safety Review Committee (SRC).
Study:
NCT06327295
Study Brief:
Protocol Section:
NCT06327295