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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Placebo matching ZYG24004 1% single administration
Placebo topical formulation matching the ZYG24004 1% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
干预措施: Placebo topical formulation (Drug)
ZYG24004 1% two administrations
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.
干预措施: ZYG24004 1% topical film-forming formulation (Drug)
ZYG24004 3% single administration
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.
干预措施: ZYG24004 3% topical film-forming formulation (Drug)
Placebo matching ZYG24004 3% single administration
Placebo topical formulation matching the 3% study drug cohort, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
干预措施: Placebo topical formulation (Drug)
ZYG24004 3% two administrations
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.
干预措施: ZYG24004 3% topical film-forming formulation (Drug)
Placebo matching ZYG24004 3% two administrations
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.
干预措施: Placebo topical formulation (Drug)
Placebo matching ZYG24004 1% two administrations
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.
干预措施: Placebo topical formulation (Drug)
ZYG24004 1% single administration
ZYG24004 1% (4 g:40 mg), topical film-forming formulation, approximately 2 g per foot (approximately 4 g total), administered once on Day 1.
干预措施: ZYG24004 1% topical film-forming formulation (Drug)