A Phase 1 interventional study of ZYG24004 1% topical film-forming formulation and ZYG24004 3% topical film-forming formulation in Tinea Pedis, sponsored by Sinomune Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Sinomune Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment
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.
The study uses a sequential cohort escalation design from lower to higher concentration and from single to two administrations. Four cohorts are planned: 1% ZYG24004 single administration, 1% ZYG24004 two administrations, 3% ZYG24004 single administration, and 3% ZYG24004 two administrations. Each cohort will enroll 16 participants randomized in a 3:1 ratio to active study drug or placebo (12 active and 4 placebo), for a total of 64 participants. Participants will have clinically diagnosed tinea pedis caused by dermatophytes, with lesions located in the interdigital area and potentially involving the sole and lateral foot, a positive fungal microscopy result at screening, and a target-foot clinical signs and symptoms score of at least 3.
The next cohort may start only after the preceding cohort completes the protocol-specified key safety and local tolerability review. Key safety/local tolerability review is planned at Day 8 +/- 1 after the first administration for single-administration cohorts and at Day 15 +/- 1 after the last administration for two-administration cohorts. The first cohort will also complete all planned pharmacokinetic sampling through Day 15 +/- 1 before the sponsor, investigators, and relevant medical/pharmacokinetic personnel assess whether later cohort pharmacokinetic sampling time points require optimization.
Safety, local tolerability, and pharmacokinetic assessments will be performed throughout the study. Preliminary efficacy will be explored using mycological outcomes and clinical signs and symptoms assessments through Day 43 +/- 2.
Exclusion Criteria:
ZYG24004 1% (4 g:40 mg), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
Drug: ZYG24004 1% topical film-forming formulation
Placebo topical formulation matching the ZYG24004 1% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
Drug: Placebo topical formulation
ZYG24004 1% (4 g:40 mg), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered on Day 1 and Day 8 +/- 1.
Drug: ZYG24004 1% topical film-forming formulation
Placebo topical formulation matching the ZYG24004 1% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered on Day 1 and Day 8 +/- 1.
Drug: Placebo topical formulation
ZYG24004 3% (4 g:0.12 g), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
Drug: ZYG24004 3% topical film-forming formulation
Placebo topical formulation matching the 3% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
Drug: Placebo topical formulation
ZYG24004 3% (4 g:0.12 g), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered on Day 1 and Day 8 +/- 1.
Drug: ZYG24004 3% topical film-forming formulation
Placebo topical formulation matching the 3% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered on Day 1 and Day 8 +/- 1.
Drug: Placebo topical 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% (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 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.
Incidence of serious adverse events (SAEs)
The type and proportion of participants experiencing any SAE will be summarized, including investigator-assessed causal relationship to study drug.
Time frame: From informed consent through Day 43 +/- 2
Incidence of Grade 3 or higher treatment-emergent adverse events (TEAEs) or TEAEs leading to withdrawal
The proportion of participants with CTCAE Version 6.0 Grade \>=3 TEAEs or TEAEs leading to withdrawal will be summarized by event type, severity, and relationship to study drug.
Time frame: From first administration through Day 43 +/- 2
Incidence and severity of local tolerability reactions at the application site
Local tolerability reactions include erythema, edema, burning/stinging, pruritus, blisters, pain, and other local symptoms. Frequency, type, severity, duration, and the proportion of participants with local tolerability reactions leading to treatment interruption or discontinuation will be summarized.
Time frame: From first administration through Day 43 +/- 2
Plasma concentration-time profile of efinaconazole and metabolite H3
Plasma concentrations of efinaconazole and its major metabolite H3 will be measured at protocol-specified pharmacokinetic time points.
Time frame: 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
Cmax will be calculated using non-compartmental analysis where data permit.
Time frame: 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
Tmax will be calculated using non-compartmental analysis where data permit.
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
AUC0-t will be calculated using non-compartmental analysis where data permit.
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
AUC0-inf will be calculated using non-compartmental analysis where data permit.
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Terminal elimination half-life (t1/2) of efinaconazole and metabolite H3
t1/2 will be calculated using non-compartmental analysis where data permit.
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Mycological cure rate of the target area
Mycological cure is defined as both fungal microscopy and fungal culture being negative for the target area.
Time frame: Week 1, Week 2, Week 4, and Week 6 after first administration
Time to mycological negativity
Time from first administration to the first visit at which mycological testing is negative. Mycological negativity is based on negative fungal microscopy and negative fungal culture.
Time frame: From first administration through Week 6
Change from baseline in clinical signs and symptoms score
Clinical signs and symptoms include scaling, erythema, pruritus, crusting, maceration, fissures, pustules, and blisters, each scored on a 0 to 3 scale, where 0 = absent and 3 = severe.
Time frame: Week 2, Week 4, and Week 6 after first administration
Treatment success rate at Week 6
Treatment success is defined as mycological cure and a total clinical signs and symptoms score \<=2, with crusting, fissures, pustules, and blisters each scored 0 and scaling, erythema, maceration, and pruritus each scored 0 or 1.
Time frame: Week 6 after first administration
Plan to share: Undecided — The IPD sharing plan has not been determined at this time.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sinomune Pharmaceutical Co., Ltd