Atopic Dermatitis Eczema
Conditions
Interventions
0.3% M528101
Sponsors
Maruho Co,Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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; 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are safety, tolerability and PK after IMP is administered once a day in part A and B and three times a day for 14 days in Part C. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints • Change from baseline in EASI total score in part C. • Change from baseline in SCORAD total score and each component signs and symptoms of AD in part C (erythema, induration/papulation, exudation, excoriation, lichenification). • Change from baseline in treatable BSA in part C. • Change in NRS itch score (Peak pruritus NRS, average NRS) from Baseline to Day 14 for Part C. • Time course change in NRS itch score in Part B. • Time course change in NRS itch score (Daytime 12 hr itch and nighttime 12 hr itch) in Part C. • Change of nighttime duration of scratching in Part C. • Change in NRS sleeplessness in Part C. | — |
Countries
Netherlands
Outcome results
None listed