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

NCT07668999 | Not Yet Recruiting Phase 1

• 2 other identifiers: ZYG-24004-Ⅰ-01-2025-03CTR20262184
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ZYG24004; tinea pedis; Phase 1b; topical film-forming formulation

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Week 1, Week 2, Week 4, and Week 6 after first administration

• Time to mycological negativity

  From first administration through Week 6

• Change from baseline in clinical signs and symptoms score

  Week 2, Week 4, and Week 6 after first administration

• Treatment success rate at Week 6

  Week 6 after first administration

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo topical formulation

Interventions

ZYG24004 1% topical film-forming formulation DRUG

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 1% single administration; ZYG24004 1% two administrations

ZYG24004 3% topical film-forming formulation DRUG

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.

ZYG24004 3% single administration; ZYG24004 3% two administrations

Placebo topical formulation DRUG

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.

Placebo matching ZYG24004 1% single administration; Placebo matching ZYG24004 1% two administrations; Placebo matching ZYG24004 3% single administration; Placebo matching ZYG24004 3% two administrations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sinomune Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruoyu Li, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaheng Wang

CONTACT

+86-15312798046; wangyaheng@sinomune.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 10, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CN (1)