Tinea PedisPhase 1NCT07668999
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
A Phase 1 study testing ZYG24004 1% topical film-forming formulation and ZYG24004 3% topical film-forming formulation in people with Tinea Pedis, run by Sinomune Pharmaceutical Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- ZYG24004 1% topical film-forming formulation and ZYG24004 3% topical film-forming formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2026to 10 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willing and able to comply with scheduled visits and protocol requirements, and able to understand and sign the informed consent form.
Who cannot join
- Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration.
- Concomitant onychomycosis of the feet or other active fungal disease.
- Bacterial or viral skin infection of the feet, or severe skin disease judged by the investigator to affect study assessments, such as severe eczema, psoriasis, atopic dermatitis, or chronic dermatitis.
- History of dermatophyte infection that was ineffective to prior antifungal therapy.
- Use of systemic antifungal drugs within 3 months before enrollment.
- Use of topical antifungal drugs, such as terbinafine cream, butenafine cream, ciclopirox, clotrimazole, or miconazole, or topical corticosteroid-containing drugs within 4 weeks before enrollment.
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- Use of topical antibacterial drugs, disinfectants, keratolytic agents such as salicylic acid, or other topical treatment on the feet within 2 weeks before enrollment.
- Use of oral antihistamines within 1 week before enrollment.
- Use of systemic corticosteroids or immunosuppressive drugs within 4 weeks before enrollment.
- Serious or uncontrolled cardiovascular, hepatic, renal, neurological, psychiatric, or immune system disease.
- History of diabetes mellitus or fasting blood glucose above the upper limit of normal.
- Clinically significant abnormalities in physical examination, hematology, blood chemistry, urinalysis, 12-lead electrocardiogram, infectious disease screening, coagulation function, or other assessments.
- Currently participating in another clinical trial, or participation in another clinical trial within 30 days before the baseline visit or within 5 half-lives of the investigational product, whichever is longer.
- Known severe allergy or intolerance to ZYG24004 or any excipients of the formulation, including film-forming polymers or ethanol.
- Addiction to smoking, defined as >10 cigarettes per day.
- Diagnosis of alcohol dependence or drug dependence within the past 12 months, or any situation judged by the investigator to affect compliance.
- Any other condition that, in the investigator's opinion, may interfere with study results or make participation unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ruoyu Li, MD, +86-13301152845, mycolab@126.com
Ruoyu Li, MD
About this study
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
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.
Read the detailed description
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.
- Conditions
- Tinea Pedis
- Being tested
- ZYG24004 1% topical film-forming formulation, ZYG24004 3% topical film-forming formulation, Placebo topical formulation
- Keywords
- ZYG24004, tinea pedis, Phase 1b, topical film-forming formulation
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYG24004 1% topical film-forming formulationDrug
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 formulationDrug
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 formulationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ZYG24004 1% single administration | Experimental | ZYG24004 1% (4 g:40 mg), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. Receives: Drug: ZYG24004 1% topical film-forming formulation |
| Placebo matching ZYG24004 1% single administration | Placebo comparator | Placebo topical formulation matching the ZYG24004 1% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. Receives: Drug: Placebo topical formulation |
| ZYG24004 1% two administrations | Experimental | 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. Receives: Drug: ZYG24004 1% topical film-forming formulation |
| Placebo matching ZYG24004 1% two administrations | Placebo comparator | 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. Receives: Drug: Placebo topical formulation |
| ZYG24004 3% single administration | Experimental | 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. Receives: Drug: ZYG24004 3% topical film-forming formulation |
| Placebo matching ZYG24004 3% single administration | Placebo comparator | Placebo topical formulation matching the 3% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. Receives: Drug: Placebo topical formulation |
| ZYG24004 3% two administrations | Experimental | 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. Receives: Drug: ZYG24004 3% topical film-forming formulation |
| Placebo matching ZYG24004 3% two administrations | Placebo comparator | 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. Receives: Drug: Placebo topical formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Secondary outcomes (4)
Mycological cure rate of the target area
Mycological cure is defined as both fungal microscopy and fungal culture being negative for the target area.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start21 Jul 2026
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinomune Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruoyu Li, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668999
- Sponsor's protocol ID
- ZYG-24004-Ⅰ-01-2025-03
- Other IDs
- CTR20262184
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan has not been determined at this time.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07668999
- Acronym / sponsor ID
- ZYG-24004-Ⅰ-01-2025-03
- Conditions
- Tinea Pedis
- Keywords
- ZYG24004, tinea pedis, Phase 1b, topical film-forming formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sinomune Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ZYG24004 1% single administration | Experimental | Drug: ZYG24004 1% topical film-forming formulationZYG24004 1% (4 g:40 mg), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. |
| Placebo matching ZYG24004 1% single administration | Placebo comparator | Drug: Placebo topical formulationPlacebo topical formulation matching the ZYG24004 1% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. |
| ZYG24004 1% two administrations | Experimental | Drug: ZYG24004 1% topical film-forming formulationZYG24004 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. |
| Placebo matching ZYG24004 1% two administrations | Placebo comparator | Drug: Placebo topical formulationPlacebo 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. |
| ZYG24004 3% single administration | Experimental | Drug: ZYG24004 3% topical film-forming formulationZYG24004 3% (4 g:0.12 g), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. |
| Placebo matching ZYG24004 3% single administration | Placebo comparator | Drug: Placebo topical formulationPlacebo topical formulation matching the 3% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1. |
| ZYG24004 3% two administrations | Experimental | Drug: ZYG24004 3% topical film-forming formulationZYG24004 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. |
| Placebo matching ZYG24004 3% two administrations | Placebo comparator | Drug: Placebo topical formulationPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration.
- Concomitant onychomycosis of the feet or other active fungal disease.
- Bacterial or viral skin infection of the feet, or severe skin disease judged by the investigator to affect study assessments, such as severe eczema, psoriasis, atopic dermatitis, or chronic dermatitis.
- History of dermatophyte infection that was ineffective to prior antifungal therapy.
- Use of systemic antifungal drugs within 3 months before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZYG24004 1% topical film-forming formulationZYG24004 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 1% single administration, ZYG24004 1% two administrations |
| ZYG24004 3% topical film-forming formulationZYG24004 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 | ZYG24004 3% single administration, ZYG24004 3% two administrations |
| Placebo topical formulationPlacebo 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. | Drug | Placebo matching ZYG24004 1% single administration, Placebo matching ZYG24004 1% two administrations, Placebo matching ZYG24004 3% single administration, Placebo matching ZYG24004 3% two administrations |
Primary outcome
Incidence of serious adverse events (SAEs)
Time frame: From informed consent through Day 43 +/- 2
The type and proportion of participants experiencing any SAE will be summarized, including investigator-assessed causal relationship to study drug.
Incidence of Grade 3 or higher treatment-emergent adverse events (TEAEs) or TEAEs leading to withdrawal
Time frame: From first administration through Day 43 +/- 2
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.
Incidence and severity of local tolerability reactions at the application site
Time frame: From first administration through Day 43 +/- 2
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.
Plasma concentration-time profile of efinaconazole and metabolite H3
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Plasma concentrations of efinaconazole and its major metabolite H3 will be measured at protocol-specified pharmacokinetic time points.
Maximum observed plasma concentration (Cmax) of efinaconazole and metabolite H3
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Cmax will be calculated using non-compartmental analysis where data permit.
Time to maximum observed plasma concentration (Tmax) of efinaconazole and metabolite H3
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
Tmax will be calculated using non-compartmental analysis where data permit.
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
AUC0-t will be calculated using non-compartmental analysis where data permit.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
AUC0-inf will be calculated using non-compartmental analysis where data permit.
Terminal elimination half-life (t1/2) of efinaconazole and metabolite H3
Time frame: Single-administration cohorts: Day 1 through Day 15 +/- 1; two-administration cohorts: Day 1 through Day 22 +/- 1
t1/2 will be calculated using non-compartmental analysis where data permit.
4 secondary outcomes
Mycological cure rate of the target area
Time frame: Week 1, Week 2, Week 4, and Week 6 after first administration
Time to mycological negativity
Time frame: From first administration through Week 6
Change from baseline in clinical signs and symptoms score
Time frame: Week 2, Week 4, and Week 6 after first administration
Treatment success rate at Week 6
Time frame: Week 6 after first administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan has not been determined at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruoyu Li, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZYG24004 1% topical film-forming formulation and ZYG24004 3% topical film-forming formulation in people with Tinea Pedis, run by Sinomune Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaheng Wang (+86-15312798046, wangyaheng@sinomune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs) (time frame: From informed consent through Day 43 +/- 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.