Evaluating ATB1651 for treating mild to moderate onychomycosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the

This study is testing a new topical treatment called ATB1651 to see if it can help adults with mild to moderate toenail fungus feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: AmtixBio Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT06327295 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ATB1651 when applied topically to the great toenail of adults with mild to moderate onychomycosis. The study will enroll up to 120 participants across multiple cohorts, with participants receiving either ATB1651 or a placebo in a 5:1 ratio. Dosing will begin with the first cohort, followed by subsequent cohorts based on safety evaluations. The study will also include an optional cohort for a higher concentration of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with confirmed mild to moderate onychomycosis affecting 20% to 60% of their great toenails.

Not a fit: Patients with severe onychomycosis or those with significant medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective topical option for patients suffering from onychomycosis.

How similar studies have performed: Other studies have shown promise with similar topical treatments for onychomycosis, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).
2. 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.
3. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is \< 2 mm.
4. Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.
5. 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.
6. Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening.

Exclusion Criteria:

1. History of allergy to any of the excipients in ATB1651.
2. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.
3. 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.
4. 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.
5. 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.
6. Diabetes mellitus requiring treatment other than diet and exercise.

Where this trial is running

Christchurch

• New Zealand Clinical Research Christchurch — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Jason (Jong-Seung) Lee

Conditions Onychomycosis