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

NCT ID: NCT01488201

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Psoriasis

Keywords

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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KHK4827

Group Type EXPERIMENTAL

KHK4827

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

KHK4827

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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4827-001

Identifier Type: -

Identifier Source: org_study_id