NL-OMON50835
Completed
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 - Phase I study of M528101
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Maruho Co,Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
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
Outcomes
Primary Outcomes
Not specified
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