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A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Sponsor: Sinomune Pharmaceutical Co., Ltd
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2026-07-03
Completion Date
2027-06-10
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
ZYG24004 1% topical film-forming formulation
ZYG24004 1% (4 g:40 mg) topical film-forming formulation. Approximately 2 g will be applied to each foot, with a total dose of approximately 4 g per administration, according to the protocol.
ZYG24004 3% topical film-forming formulation
ZYG24004 3% (4 g:0.12 g) topical film-forming formulation. Approximately 2 g will be applied to each foot, with a total dose of approximately 4 g per administration, according to the protocol.
Placebo topical formulation
Placebo topical formulation matching ZYG24004 in appearance and packaging. Approximately 2 g will be applied to each foot, with a total dose of approximately 4 g per administration, according to the protocol.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China