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

Kyowa Kirin Co., Ltd.48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psoriasis

Interventions

PlaceboDRUG

KHK4827DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Safety

* Adverse events * Clinical laboratory test data * Vital signs

Secondary Outcomes

Plasma KHK4827 concentrations and pharmacokinetic parameters

To assess PK parameters which include * area under the plasma concentration versus time curve (AUC) * peak plasma concentration (Cmax) * t1/2 * CL

Time frame: 16 time points up to 64 days

Data from ClinicalTrials.gov

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