A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects with Atopic Dermatitis
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-jRCT2080224566
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 120
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
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/uL
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events<br>Laboratory data<br>Vital signs<br>Standard 12-lead ECG
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>Serum KHK4323 concentration<br>Pharmacokinetic parameters (tmax, Cmax, AUC, etc.)<br>Anti-KHK4323 antibodies