Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.
Interventions
DRUGPlacebo
DRUGKHK4827
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Health volunteers * Able to provide written informed consent * Healthy male between 20 to 45 years of age, inclusive at the time of screening * Additional inclusion criteria apply Psoriasis subjects * 20 to 70 years of age, inclusive at the time of screening * Active but clinically stable, plaque psoriasis * Psoriasis involving ≥10% of the body surface area * A minimum PASI score of ≥10 obtained during the screening period * Additional inclusion criteria apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | — | * Adverse events * Clinical laboratory test data * Vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma KHK4827 concentrations and pharmacokinetic parameters | 16 time points up to 64 days | To assess PK parameters which include * area under the plasma concentration versus time curve (AUC) * peak plasma concentration (Cmax) * t1/2 * CL |
Countries
Japan
Outcome results
None listed