A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Launched by AMTIXBIO CO., LTD. · Mar 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ATB1651 for adults with a fungal nail infection known as onychomycosis, which affects the toenails. The goal is to evaluate how safe the treatment is, how well it is tolerated, and how it behaves in the body. The trial is currently looking for participants between the ages of 18 and 70 who have been diagnosed with onychomycosis affecting 20% to 60% of one or both big toenails. Participants must also be in generally good health without serious medical conditions.

If you qualify and decide to take part, you will receive the study treatment and be monitored for any side effects or reactions. It's important to note that participants will need to stop using nail products during the study and may have some health checks to ensure they are suitable for the trial. This is a great opportunity to contribute to research while potentially finding relief from this condition.

Gender

ALL

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.