Recruiting
Phase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Condition(s) studied
Tinea Pedis
Investigational drug(s) / intervention(s)
ZYG24004 1% topical film-forming formulationZYG24004 3% topical film-forming formulationPlacebo topical formulation
ZYG24004 1% topical film-forming 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% topical film-forming formulation: 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: 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 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.
Eligibility
Inclusion Criteria:
1. 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.
2. Clinically diagnosed tinea pedis, with lesions located in the interdigital area and possibly involving the sole and lateral foot.
3. Positive mycological test of the target foot at screening, based on fungal microscopy.
4. Target-foot clinical signs and symptoms score \>=3.
5. In generally good health, with no serious or uncontrolled systemic disease, and considered by the investigator to be suitable for participation.
6. 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.
7. Willing and able to comply with scheduled visits and protocol requirements, and able to understand and sign the informed consent form.
Exclusion Criteria:
1. Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration.
2. Concomitant onychomycosis of the feet or other active fungal disease.
3. 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.
4. History of dermatophyte infection that was ineffective to prior antifungal therapy.
5. Use of systemic antifungal drugs within 3 months before enrollment.
6. 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.
7. Use of topical antibacterial drugs, disinfectants, keratolytic agents such as salicylic acid, or other topical treatment on the feet within 2 weeks before enrollment.
8. Use of oral antihistamines within 1 week before enrollment.
9. Use of systemic corticosteroids or immunosuppressive drugs within 4 weeks before enrollment.
10. Serious or uncontrolled cardiovascular, hepatic, renal, neurological, psychiatric, or immune system disease.
11. History of diabetes mellitus or fasting blood glucose above the upper limit of normal.
12. Clinically significant abnormalities in physical examination, hematology, blood chemistry, urinalysis, 12-lead electrocardiogram, infectious disease screening, coagulation function, or other assessments.
13. 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.
14. Known severe allergy or intolerance to ZYG24004 or any excipients of the formulation, including film-forming polymers or ethanol.
15. Addiction to smoking, defined as \>10 cigarettes per day.
16. Diagnosis of alcohol dependence or drug dependence within the past 12 months, or any situation judged by the investigator to affect compliance.
17. Any other condition that, in the investigator's opinion, may interfere with study results or make participation unsafe.
Primary outcome measure(s)
- Incidence of serious adverse events (SAEs) — 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 — 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 — 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 — 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 — 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 — 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) — 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) — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Peking University First Hospital |
Beijing |
Beijing Municipality |
Recruiting |
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