Status:
TERMINATED
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03846466
Start Date
February 22 2019
End Date
December 11 2019
Last Update
January 28 2020
Active Locations (1)
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1
Osaka Pharmacology Clinical research Hospital
Osaka, Japan