Actively Recruiting
A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
Led by AmtixBio Co., Ltd. · Updated on 2025-02-19
120
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
CONDITIONS
Official Title
A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed onychomycosis by positive mycological (KOH) staining and culture from affected great toenail(s)
- Onychomycosis involving 20% to 60% of one or both great toenails as determined by visual inspection
- Combined thickness of the distal nail plate less than 2 mm at the hyperkeratotic nail bed
- Adults aged 18 to 70 years at screening
- In good general health with no significant medical history or clinically significant abnormalities on physical exam or ECG
- Body mass index between 17.5 and 35.0 kg/m2 at screening
You will not qualify if you...
- Allergy to any excipients in ATB1651
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or HIV antibody at screening or day 1
- Physical or psychological conditions that would likely prevent compliance with the study protocol
- Unwillingness to avoid nail cosmetics from screening until study end
- Use of investigational drugs or medical devices within 30 days prior to screening or participation in more than 4 investigational drug studies within the past year
- Diabetes mellitus requiring treatment other than diet and exercise
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research Christchurch
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
J
Jason (Jong-Seung) Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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