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Completed

NCT Number: NCT01488201

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

KHK4827

Drug

Primary outcomes

  1. Safety

    • Adverse events
    • Clinical laboratory test data
    • Vital signs

Secondary outcomes

  1. Plasma KHK4827 concentrations and pharmacokinetic parameters

    Time frame: 16 time points up to 64 days

    To assess PK parameters which include

    • area under the plasma concentration versus time curve (AUC)
    • peak plasma concentration (Cmax)
    • t1/2
    • CL

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and Subjects With Moderate to Severe Psoriasis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2011
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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