Evaluating ATB1651 for treating mild to moderate onychomycosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• New Zealand Clinical Research Christchurch
  Christchurch, New Zealand Recruiting

Study contacts

• Study coordinator: Jason (Jong-Seung) Lee
• Email: jason_lee@amtixbio.com
• Phone: 31 5175 8215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.