Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT03846466
Eligibility Criteria:
Inclusion Criteria:
Part 1:
* Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
* BMI ≥ 18.5 to \< 30.0 at time of screening tests
Part 2:
* Men and women aged 18 years or older at the time of consent
* Patients with EASI ≥ 16 in pre-administration testing
* Patients with IGA of "3: Moderate" or higher in pre-administration testing
* Patients with BSA ≥ 10% at screening in pre-administration testing
"Exclusion Criteria:
Part 1:
* Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
* Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
* Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
* Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
* Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
* Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period
Part 2:
* Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c \> 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
* Patients observed to have one of the following laboratory test abnormalities in screening tests
* Neutrophil count: \< 1500/μL
* Serum creatinine: \> 1.5 mg/dL
* AST or ALT: \> 2.5-fold the upper limit of the reference range
* Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03846466
Study Brief:
Protocol Section:
NCT03846466