A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
ConditionTinea Pedis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSinomune Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ZYG24004 1% topical film-forming formulation
DrugZYG24004 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 formulation
DrugZYG24004 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
DrugPlacebo 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.
Treatment groups
64 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: ZYG24004 1% single administrationExperimental treatment 1 intervention
Group B: Placebo matching ZYG24004 1% single administrationPlacebo comparator 1 intervention
Group C: ZYG24004 1% two administrationsExperimental treatment 1 intervention
Group D: Placebo matching ZYG24004 1% two administrationsPlacebo comparator 1 intervention
Group E: ZYG24004 3% single administrationExperimental treatment 1 intervention
Group F: Placebo matching ZYG24004 3% single administrationPlacebo comparator 1 intervention
Group G: ZYG24004 3% two administrationsExperimental treatment 1 intervention
Group H: Placebo matching ZYG24004 3% two administrationsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 +/- 22
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 +/- 23
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 +/- 24
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 +/- 1Secondary outcomes
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 administration2
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 63
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 administration4
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 administrationSponsors and contacts
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Source ClinicalTrials.gov