NL-OMON50835已完成不适用
Phase I, Randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, PK and efficacy of M528101 in Healthy Volunteers and AD subjects - Phase I study of M528101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Subjects who meet all of the following criteria are eligible to participate in
- •this study:
- •1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is
- •defined by absence of evidence of any active or chronic disease following a
- •detailed medical and surgical history, a complete physical examination
- •including vital signs, 12-lead ECG, hematology, blood chemistry, blood serology
- •and urinalysis;
- •3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum
- •weight of 50 kg;
- •3. Subjects must use effective contraception for the duration of the study;
- •4. Able and willing to give written informed consent and to comply with the
- •study restrictions;
- •5. Subject has a negative result of COVID-19 test at Day -1.
- •Part B and C
- •1. Male subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,
- •inclusive; Healthy status is defined by absence of evidence of any active or
- •chronic disease except for atopic dermatitis following a detailed medical and
- •surgical history, a complete physical examination including vital signs,
- •12-lead ECG, hematology, blood chemistry, blood serology and urinalysis;
- •2. Diagnosed with AD according to the Hanifin & Rajka criteria;
- •3. Body mass index (BMI )>=18 kg/m2, with a minimum of 50 kg;
- •4. Subjects must use effective contraception for the duration of the study;
- •5. Suitable target lesions defined as eczema lesions of 3- 10% BSA (excluding
- •the head, face and genitals)
- •In part C, the first 6 subjects have eczema lesions with 3 to 5% BSA and 3
- •subjects have 8 to 10% BSA;
- •6. Subject has a negative result of COVID-19 test at Day -1;
- •7. Average Pruritus (AP) NRS *3 at Screening and AP NRS*5 at Day1. The AP NRS
- •score for each visits will be determined by a single AP NRS assessment
- •(ranging from 0 to 10) of the past 24-hours.
- •Inclusion Criteria Part C only
- •8. Average of daily AP NRS*5 at Day 1 The average of daily AP NRS score will be
- •determined based on the average of Daily AP NRS scores (score ranging from 0 to
- •10) of the past three days.
排除标准
- •Exclusion Criteria part A
- •1. Any disease associated with immune system impairment, including auto-immune
- •diseases, allergies, HIV and transplantation patients;
- •2. History of pathological scar formation (keloid, hypertrophic scar);
- •3. Excessive sun exposure or a tanning booth within 21 days prior to Day 1;
- •4. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times a year;
- •5. Loss or donation of blood over 500 mL within three months prior to
- •screening. Or the donation of plasma within 14 days prior to screening;
- •6. Current smoker and/or regular user, of other nicotine-containing products
- •(e.g., patches). Regular users are defined as someone who smokes more than 10
- •cigarettes per day;
- •7. History of or current drug or substance abuse considered significant by the
- •PI (or medically qualified designee), including a positive urine drug screen;
- •8. Subject has a body temperature of >38.0 °C at screening and/or Day 1;
- •9. Have known history of atopy;
- •10. No prescription medications and OTC medications will be permitted within 21
- •days prior to study drug administrations, or less than 5 half-lives (whichever
- •is longer, and during the course of the study;
- •11. Have any current and / or recurrent pathologically, clinically significant
- •skin condition at the treatment area (i.e. atopic dermatitis).
- •Exclusion Criteria part B and C
- •1. Any disease associated with immune system impairment, including auto-immune
- •diseases, allergies, HIV and transplantation patients;
- •2. History of pathological scar formation (keloid, hypertrophic scar);
- •3. Excessive sun exposure or a tanning booth within 21 days prior to Day 1;
- •4. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times a year;
- •5. Loss or donation of blood over 500 mL within three months prior to
- •screening. Or the donation of plasma within 14 days prior to screening;
- •6. Current smoker and/or regular user of other nicotine-containing products
- •(e.g., patches). Regular users are defined as someone who smokes more than 10
- •cigarettes per day;
- •7. History of or current drug or substance abuse considered significant by the
- •PI (or medically qualified designee), including a positive urine drug screen;
- •8. Subject has a body temperature of >38.0 °C at screening and/or Day 1;
- •9. Any topical anti-AD drugs on the lesional sites within 7 days prior to Day
- •1, for all other systemic anti-AD drugs a washout period of 4 weeks or 5
- •half-lives (whichever is longer) is required, or planned to use during the
- •course of the study;
- •10. Requirement of immunosuppressive or immunomodulatory medication within 28
- •days or 5 half-lives (whichever is longer) prior to Day 1 or planned to use
- •during the course of the study;
- •11. Use of antihistamines within 14 days prior to start of the study (Day 1).
研究者
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