NL-OMON29502招募中不适用
Phase I, Randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, PK and efficacy of M528101 in Healthy Volunteers and AD subjects
Maruho0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria part A
- •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;
- •2. 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.
- •Inclusion Criteria 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) between 18 and 30 kg/m2, inclusive, and with a minimum weight 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;
- •(ranging from 0 to 10) of the past 24-hours.
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 Day 1.
研究者
相似试验
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 subjectsEczema10014982Atopic DermatitisNL-OMON50835Maruho Co,Ltd36
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic DermatitisAtopic DermatitisNCT04544943Hoth Therapeutics, Inc.31
已完成
1 期
DLQ03 in a wound healing model in patients with atopic dermatitis (eczema)ISRCTN33393967Dermaliq Therapeutics Inc.27
已完成
1 期
KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)Lichen Simplex ChronicusNCT05454462Kamari Pharma Ltd55
已完成
2 期
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome PatientsTreatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome PatientsNCT00961896Novartis Pharmaceuticals18