A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Different Concentrations of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b study in adult participants with tinea pedis caused by dermatophytes. The study will evaluate the safety, local tolerability, and pharmacokinetic profile of two concentrations of ZYG24004 (1% and 3%) after topical administration once or twice (once weekly for two consecutive weeks), and will explore preliminary efficacy.
• Male or female participants aged 18 to 65 years; body weight \>=50 kg for males and \>=45 kg for females; body mass index (BMI) 18.5 to 28.0 kg/m2, inclusive.
• Clinically diagnosed tinea pedis, with lesions located in the interdigital area and possibly involving the sole and lateral foot.
• Positive mycological test of the target foot at screening, based on fungal microscopy.
• Target-foot clinical signs and symptoms score \>=3.
• In generally good health, with no serious or uncontrolled systemic disease, and considered by the investigator to be suitable for participation.
• The participant or the participant's partner is not pregnant or breastfeeding, and the participant agrees to use reliable contraception throughout the study and for 3 months after the last administration.
• Willing and able to comply with scheduled visits and protocol requirements, and able to understand and sign the informed consent form.