NCT06327295

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: AmtixBio Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	ATB1651-102- Cohort 1	Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
DRUG	ATB1651-102- Cohort 2	Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 20 weeks with a follow-up for 16 weeks.
DRUG	ATB1651-102- Cohort 3	Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 twice daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
DRUG	ATB1651-102- Cohort 4	Dosage form- Topical solution; Dosage- 5% formulation The participants will apply the daily dose of 5% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
DRUG	Placebo	participants will receive matching placebo across cohorts 1-4 of the study.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-30
• Completion: 2026-01-30
• First posted: 2024-03-25
• Last updated: 2025-02-19

Locations

1 site across 1 country: New Zealand