The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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
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
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
New Zealand Clinical Research Christchurch
Christchurch, New Zealand
To assess the safety and tolerability of multiple ascending doses (MAD) of ATB1651 in participants with mild to moderate onychomycosis through the percentage and severity of adverse events including pain, erythema and local irritation
Adverse Events will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher
Time frame: From baseline to end of study treatment up to 56 days
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Efficacy of ATB1651 assessed based on Mycological evaluation of the affected great toenail(s) where ATB1651 was applied
Time frame: From baseline to end of study treatment up to 56 days
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Difference in the appearance of the affected great toenail(s) as determined by photographs throughout treatment and follow-up periods
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Maximum plasma concentration and Time to maximum plasma concentration
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to 24 hours post dose
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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
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
The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to the last measurable concentration
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to infinity
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
Time frame: From baseline to end of study treatment up to 56 days