Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06327295

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

New Zealand Clinical Research Christchurch

Christchurch, New Zealand, 8011

Actively Recruiting

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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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