A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 2, 2012
November 1, 2012
10 months
December 1, 2011
November 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
* Adverse events * Clinical laboratory test data * Vital signs
Secondary Outcomes (1)
Plasma KHK4827 concentrations and pharmacokinetic parameters
16 time points up to 64 days
Study Arms (2)
KHK4827
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 8, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 2, 2012
Record last verified: 2012-11