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NOT YET RECRUITING
NCT07668999
PHASE1

A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes

Sponsor: Sinomune Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China