Atopic dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : KHK4323
INN of investigational material : -
Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammatory agents
Dosage and
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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 = 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
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse events Laboratory data Vital signs Standard 12-lead ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Serum KHK4323 concentration Pharmacokinetic parameters (tmax, Cmax, AUC, etc.) Anti-KHK4323 antibodies | — |
Countries
Japan
Outcome results
None listed