Clinical trial NCT05089409: A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Onychomycosis
Lead sponsor: AmtixBio Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Confirmation of onychomycosis by mycological staining and/or culture from affected great toenail(s).
2. Appearance of onychomycosis involving 20% to 70% of 1 (or both) affected great toenail(s) as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Investigator, participation can be considered in consultation with the Medical Monitor.
3. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is less than 3 mm.
4. Medically healthy with clinically insignificant Screening results (eg, laboratory profiles, medical history, ECGs, physical exam), as judged by the PI.
5. Negative urine drug screen and alcohol breath test at Screening and Day 1.
6. Body Mass Index (BMI) between 17.5 and 35.0, inclusive.
7. Agree to adhere to the current state and national advice regarding minimizing exposure to coronavirus disease of 2019 (COVID-19) from the Screening visit until the EOS visit.

Exclusion Criteria:

1. History of allergy to any of the excipients in ATB1651.
2. Positive COVID-19 test at Screening or any symptoms consistent with COVID-19 prior to initial dosing.
3. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
4. Have any underlying physical or psychological medical conditions that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study.
5. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
6. Unwilling to refrain from the use of nail cosmetics such as clear and/ or colored nail lacquers from the Screening visit until the end of the study.
7. Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.

Primary outcomes:
measure: 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
timeFrame: From baseline to end of study treatment up to 56 days
Secondary outcomes:
measure: To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
timeFrame: From baseline to end of study treatment up to 56 days
measure: 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
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
timeFrame: From baseline to end of study treatment up to 56 days
measure: 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
timeFrame: From baseline to end of study treatment up to 56 days
measure: 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
timeFrame: From baseline to end of study treatment up to 56 days
measure: 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
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
timeFrame: From baseline to end of study treatment up to 56 days
measure: To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
timeFrame: From baseline to end of study treatment up to 56 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research Christchurch
Study officials:
References: