A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
1 other identifier
interventional
120
1 country
1
Brief Summary
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedFebruary 19, 2025
February 1, 2025
12 months
February 29, 2024
February 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis.
Complete cure rate (defined as 100% clear nail surface area for the target toenail at Week 36 and negative mycological evaluation of the affected great toe after the last dosing).
From screening to end of study treatment up to 252 days
Secondary Outcomes (10)
To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis.
From screening to end of study treatment up to 252 days
To assess and collect the percentage and severity of adverse events (AEs).
From screening to end of study treatment up to 252 days
Maximum plasma concentration (Cmax)
Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Time to maximum plasma concentration (Tmax)
Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal elimination rate constant (λz)
Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
- +5 more secondary outcomes
Study Arms (5)
ATB1651-102 Cohort 1
EXPERIMENTALThe planned ATB1651 dose of 3% solution to each infected toenail once daily for 12 weeks (follow up for 24 weeks) Twenty-five participants are expected to enroll per cohort.
ATB1651-102 Cohort 2
EXPERIMENTALThe planned ATB1651 dose of 3% solution to each infected toenail once daily for 20 weeks follow up for 16 weeks) Twenty-five participants are expected to enroll per cohort.
ATB1651-102 Cohort 3
EXPERIMENTALThe planned ATB1651 dose of 3% solution to each infected toenail twice daily for 12weeks follow up for 24 weeks). Twenty-five participants are expected to enroll per cohort.
ATB1651-102 Cohort 4
EXPERIMENTALThe planned ATB1651 dose of 5% solution to each infected toenail once daily for 12weeks follow up for 24 weeks). Twenty-five participants are expected to enroll per cohort.
Placebo
PLACEBO COMPARATORMatching placebo to the IP per cohort. Five participants are expected to be enrolled per cohort.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).
- Appearance of onychomycosis involving 20% to 60% 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 Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment.
- The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is \< 2 mm.
- Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.
- In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination or ECG at Screening and/or before the first administration of IP at the discretion of the PI or designee. Participants with mild stable disease may be considered eligible at the discretion of the PI or designee.
- Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening.
You may not qualify if:
- History of allergy to any of the excipients in ATB1651.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.
- Underlying physical or psychological medical conditions that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- 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.
- 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.
- Diabetes mellitus requiring treatment other than diet and exercise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Zealand Clinical Research Christchurch
Christchurch, 8011, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 25, 2024
Study Start
July 1, 2024
Primary Completion
June 30, 2025
Study Completion
January 30, 2026
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share