A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Brodalumab

Criteria

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