Phase I study of M528101

Recruiting

Conditions: Atopic dermatitis

Registration Number: NL-OMON29502

Lead Sponsor: Maruho

Brief Summary: .A.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

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;
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.

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 Day 1.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of M528101 after topical administration<br>To evaluate systemic exposure of M528101 after topical administration and establish PK profile if possible

Secondary Outcome Measures