Not Yet RecruitingPhase 1

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

China64 participantsStarted 2026-07-03

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of serious adverse events (SAEs)

Timeframe: From informed consent through Day 43 +/- 2

Incidence of Grade 3 or higher treatment-emergent adverse events (TEAEs) or TEAEs leading to withdrawal

Timeframe: From first administration through Day 43 +/- 2

Incidence and severity of local tolerability reactions at the application site

Timeframe: From first administration through Day 43 +/- 2

Plasma concentration-time profile of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

Maximum observed plasma concentration (Cmax) of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

Time to maximum observed plasma concentration (Tmax) of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

Trial details

NCT IDNCT07668999

SponsorSinomune Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-10

Contact for this trial

Yaheng Wang

+86-15312798046 wangyaheng@sinomune.com

View on ClinicalTrials.gov More Tinea Pedis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

Incidence of serious adverse events (SAEs)

Timeframe: From informed consent through Day 43 +/- 2

Incidence of Grade 3 or higher treatment-emergent adverse events (TEAEs) or TEAEs leading to withdrawal

Timeframe: From first administration through Day 43 +/- 2

Incidence and severity of local tolerability reactions at the application site

Timeframe: From first administration through Day 43 +/- 2

Plasma concentration-time profile of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

Maximum observed plasma concentration (Cmax) of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

Time to maximum observed plasma concentration (Tmax) of efinaconazole and metabolite H3

Timeframe: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria