Phase I/II Study of MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis.
详细描述
The study includes 2 parts: The first part (Phase I) is the first-in-human trial of MH004, consisting of a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part is a multi-center, randomized, double-Blind, vehicle-controlled phase II study to evaluate the safety, tolerability and PK of MH004 Ointment for AD participants, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase I.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phase I: Adults, age 18 - 70 years old, inclusive. Phase II: Adolescents aged ≥ 12 to 17 years, inclusive. Adults, age 18 - 70 years old, inclusive, at time of screening.
- •Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day
- •Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- •Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
排除标准
- •Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- •Concurrent conditions and history of other diseases:
- •Immunocompromised.
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- •Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- •Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- •Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
- •Other types of eczema.
- •Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- •Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- •Previously received Janus kinase (JAK) inhibitors, systemic or topical.
- •Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
- •Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.
- •Pregnant or lactating participants, or those considering pregnancy.
- •Alcohol or drug abuse. -
研究组 & 干预措施
Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD
SAD and MAD
干预措施: MH004 0.1% Ointment (Drug)
Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD
SAD and MAD
干预措施: MH004 0.3% Ointment (Drug)
Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD
SAD and MAD
干预措施: MH004 1.0% Ointment (Drug)
Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD
SAD and MAD
干预措施: MH004 3.0% Ointment (Drug)
Phase II. MH004 (0.1%) in Atopic Dermatitis
28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
干预措施: MH004 0.1% Ointment (Drug)
Phase II. MH004 (0.3%) in Atopic Dermatitis
28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
干预措施: MH004 0.3% Ointment (Drug)
Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis
28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
干预措施: MH004 1.0% Ointment (Drug)
Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis
28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
干预措施: MH004 3.0% Ointment (Drug)
Phase I. Vehicle Ointment in healthy volunteers SAD and MAD
SAD and MAD
干预措施: Vehicle Ointment (Drug)
Phase II. Vehicle Ointment in Atopic Dermatitis
28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
干预措施: Vehicle Ointment (Drug)
结局指标
主要结局
Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: 1 year
Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomization until Day 14 for MAD participants. The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.
Phase II: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With MH004 Ointment
时间窗: Baseline and week 4.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
次要结局
- Phase I: Characterization of Pharmacokinetics (Cmax) of MH004 Ointment in Healthy Volunteers or Participants With Mild to Moderate Atopic Dermatitis(Up to 6 Months)
- Phase II: Mean Percentage Change From Baseline in EASI Score at Week 2(Baseline, Week 2)
- Percentage of Participants Who Achieve a ≥ 50% or ≥ 75% Improvement From Baseline in EASI (EASI-50 or EASI-75) at Weeks 4(Baseline, Week 4)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 4(Baseline, Week 4)
- Mean Change From Baseline in the Scoring in Atopic Dermatitis at Week 4(Baseline, Week 4)
- Number of Participants With At Least One Adverse Event (AEs) and as Per Severity(Up to Week 24)