NL-OMON29502
Recruiting
Not Applicable
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 sites36 target enrollmentTBD
ConditionsAtopic dermatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic dermatitis
- Sponsor
- Maruho
- Enrollment
- 36
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
.A.
Investigators
Eligibility Criteria
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;
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;
Outcomes
Primary Outcomes
Not specified
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