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

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ClinicalTrials.gov Identifier: NCT01488201
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : November 2, 2012
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Drug: Placebo Drug: KHK4827 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: KHK4827 Drug: KHK4827
Placebo Comparator: Placebo Drug: Placebo



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


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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

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

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01488201     History of Changes
Other Study ID Numbers: 4827-001
First Posted: December 8, 2011    Key Record Dates
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