Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK4083 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4083 | Drug | IV administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature | Up to 22 weeks post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Serum KHK4083 concentration | Up to 22 weeks post drug administration | |
| Maximum concentration (Cmax) | Up to 22 weeks post drug administration | |
| Time to reach Cmax (tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any of the following clinically significant concurrent illnesses:
Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
Past or current history of drug allergy
Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
Any planned surgical treatment during the study
Any skin disease that may affect the clinical symptom assessment
Pregnant or lactating women, or women willing to have a child during the study period
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Closed information | Sapporo | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627613 | KHK4083 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 22 weeks post drug administration |
| Area under the curve (AUC) | Up to 22 weeks post drug administration |
| Anti-KHK4083 antibody production | Up to 22 weeks post drug administration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |