A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
- Registration Number
- NCT01488201
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KHK4827 KHK4827 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety * Adverse events
* Clinical laboratory test data
* Vital signs
- Secondary Outcome Measures
Name Time Method 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