NCT05089409

A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis

A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ATB1651 in Adults With Mild to Moderate Onychomycosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AmtixBio Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 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

Onychomycosis (also known as tinea unguium) is a contagious infection of toe nails by fungal organisms including dermatophytes, yeast, and molds. This is phase 1, first in human, randomized, double-blind, placebo-controlled, MAD study designed to assess the safety, tolerability, and PK of ATB1651 when administered in participants with mild to moderate onychomycosis. The study consists of 2 parts. In both parts, participants will receive multiple doses of ATB1651 applied to 1 affected great toenail and the remaining toenails (affected or not) Part A: Participants will be enrolled into 1 of 3 cohorts and randomized to receive either ATB1651 or placebo at a ratio of 2:1. Up to 2 additional cohorts may be added at the discretion of the Sponsor and Safety Monitoring Committee, if deemed necessary Part B: Participants will be randomized within a single cohort to receive either ATB1651 or placebo at a ratio of 4:1 There will be 18 participants enrolled in part A, 30 participants in part B

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	ATB1651, 2 mg/mL	The participants will apply daily doses of ATB1651, 2 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
DRUG	ATB1651, 5 mg/mL	The participants will apply daily doses of ATB1651, 5 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
DRUG	ATB1651, 10 mg/mL	The participants will apply daily doses of ATB1651, 10 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
DRUG	ATB1651, 20 mg/mL	The participants will apply daily doses of ATB1651, 20 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
DRUG	ATB1651, 30 mg/mL	The participants will apply daily doses of ATB1651, 30 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
OTHER	Placebo	The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days

Timeline

• Start date: 2022-03-04
• Primary completion: 2023-06-03
• Completion: 2023-09-20
• First posted: 2021-10-22
• Last updated: 2023-10-11

Locations

1 site across 1 country: New Zealand