Status:
COMPLETED
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Psoriasis
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01488201
Start Date
November 1 2011
End Date
September 1 2012
Last Update
November 2 2012
Active Locations (1)
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1
Tokyo, Japan