Back to resultsA Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Placebo
KHK4827
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KHK4827
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety
Adverse events
Clinical laboratory test data
Vital signs
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01488201
First Posted
December 1, 2011
Last Updated
November 1, 2012
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01488201
Brief Title
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KHK4827
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
KHK4827
Primary Outcome Measure Information:
Title
Safety
Description
Adverse events
Clinical laboratory test data
Vital signs
Secondary Outcome Measure Information:
Title
Plasma KHK4827 concentrations and pharmacokinetic parameters
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
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