Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- PK profile - Cohort I, II, III
研究概览
简要总结
The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.
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
- •Clinical diagnosis of AD defined according to Hanifin and Rajka.
- •Investigator Global Assessment scored as mild (2) to severe (4) AD.
- •At screening, AD lesions amenable for treatment involving 10% to < 25% (Cohort I), 25% to < 50% (Cohort II), 50% to 100% (Cohort III) and 10% to < 50% (Cohort IV) of the total BSA.
- •On Day -1, AD lesions amenable for treatment involving 10% to < 28% (Cohort I), 25% to < 55% (Cohort II), 50% to 100% (Cohort III) and 10% to < 55% (Cohort IV) of the total BSA.
- •Adult male or female subjects, aged 18 to 65 years, inclusive.
排除标准
- 未提供
研究组 & 干预措施
LEO 29102 2,5 mg/g cream
干预措施: LEO 29102 (Drug)
LEO 29102 Cream Vehicle
干预措施: LEO 29102 Cream Vehicle (Drug)
结局指标
主要结局
PK profile - Cohort I, II, III
时间窗: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)
Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort I, II, III
时间窗: 14 Days
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination
PK profile - Cohort IV
时间窗: Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42
Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort IV
时间窗: 49 Days
Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.
次要结局
- Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1)(10 Days for cohort II; 42 days for cohort IV, subgroup 1)
- Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)(10 Days for cohort I, 42 days for cohort IV, subgroup 2)