A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Onychomycosis Clinical Trial

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the

Status Not yet recruiting

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). ;

Related Conditions & MeSH terms

• Onychomycosis

• 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