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Clinical Trial Summary

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06327295
Study type Interventional
Source AmtixBio Co., Ltd.
Contact Jason (Jong-Seung) Lee
Phone 31 5175 8215
Email jason_lee@amtixbio.com
Status Not yet recruiting
Phase Phase 2
Start date March 30, 2024
Completion date January 30, 2026

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