A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
ConditionOnychomycosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAmtixBio Co., Ltd.
About this trial
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Eligibility criteria
Qualifiers
Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).
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.
The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 2 mm.
Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.
Disqualifiers
History of allergy to any of the excipients in ATB1651.
Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.
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.
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.
Trial design
Treatments tested in this trial
- ATB1651-102- Cohort 1
- ATB1651-102- Cohort 2
- ATB1651-102- Cohort 3
- ATB1651-102- Cohort 4
- Placebo
Treatment groups
120 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov