A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
NCT07668999 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-08-04
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.
Conditions
- Tinea Pedis
Interventions
- DRUG
-
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.
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
Sinomune Pharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Ruoyu Li, MD · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-21
- Primary Completion
- 2027-06-10
- Completion
- 2027-06-10
Countries
- China
Study Locations
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