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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488201
• Other study ID #: 4827-001
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2011
• Last updated: November 1, 2012
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Placebo

• KHK4827

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse events; Clinical laboratory test data; Vital signs		Yes
Secondary	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	16 time points up to 64 days	No