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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: KHK4827; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01488201

4827-001

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups, including a placebo group

KHK4827

Experimental group

Treatment:

Drug: KHK4827

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo