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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488201
First Posted: December 8, 2011
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: Placebo Drug: KHK4827 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Safety
    • Adverse events
    • Clinical laboratory test data
    • Vital signs


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 48
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 Drug: KHK4827
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488201


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01488201     History of Changes
Other Study ID Numbers: 4827-001
First Submitted: December 1, 2011
First Posted: December 8, 2011
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases