EUCTR2016-000376-26-GB进行中（未招募）1 期
A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1 Healthy males or females, aged between 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- •2 Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception. Males with partners who are WOCBP must also use contraception
- •3 Body weight of = 50 kg.
- •4 Body Mass Index of =34.9 kg/m^2.
- •5 Subjects must have a Fitzpatrick Skin Type of between I to III to be included in the study.
- •6 Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •7 Evidence of a personally signed and dated informed consent form, indicating that the subject has been informed of all pertinent aspects of the study.
- •COHORTS 2 AND 3
- •1 Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
- •2 Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception. Males with partners who are WOCBP must also use contraception
- •3 Body weight of = 50 kg.
- •4 Body Mass Index of =34.9 kg/m^2.
- •5 Eczema Area and Severity Index (EASI) of =9 and <48 at Screening and an EASI of =12 and <48 at Day 1.
- •6 An Investigator’s Global Assessment (IGA) score = 3 at both Screening and Day 1.
- •7 Atopic dermatitis affecting between =10 to <40% BSA at Screening and =10% to <50% BSA on Day 1.
- •8 Patients must be willing to stop applying their daily emollients and instead use the study emollient (E45 lotion) twice daily from at least 7 days prior to randomisation and throughout their participation in the study.
- •9 Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •10 Evidence of a personally signed and dated informed consent form, indicating that the subject has been informed of all pertinent aspects of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •2 Have tattoos covering areas of skin to be dosed.
- •3 Subjects who are hirsute in areas of skin to be dosed.
- •4 Subjects who are unwilling to stop hair removal by any means to skin areas to be dosed for 2 weeks prior to randomisation and throughout the duration of the study.
- •5 Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
- •6 Hypersensitivity to any excipients in the study ointment formulation, study emollient or study shower cream.
- •7 Hypersensitivity to any laundry detergents.
- •8 Use of a tanning booth/parlour/sunbathing (including excessive exposure to sunlight) or use of tanning products within 4 weeks before start of the study and for the duration of their participation in the study.
- •9 History of sensitivity to NSAIDs.
- •10 Clinically significant cardiac disease or ECG abnormalities. The PI should decide whether ECG abnormalities other than those listed are clinically significant and should exclude the subject from enrolment.
- •COHORTS 2 AND 3
- •1 AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study.
- •2 Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
- •3 Patients who are hirsute in areas of skin to be dosed.
- •4 Patients who are unwilling to stop hair removal by any means to skin areas to be dosed for 2 weeks prior to randomisation and throughout the duration of the study.
- •5 Hypersensitivity to any excipients in the study ointment formulation, study emollient or study shower cream.
- •6 Hypersensitivity to any laundry detergents (Cohort 2 only).
- •7 Have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g. immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the study. All other biologics should not have been used within 3 months of the start of study.
- •8 Have received systemic corticosteroids within 4 weeks of the start of the study. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
- •9 Patients treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting study; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
- •10 Use of a tanning booth/parlour/sunbathing or use of tanning products within 4 weeks before start of the study and for the duration of their participation in the study.
- •11 Have used antiseptic treatments (e.g. bleach baths, potassium permanganate etc.) with
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