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Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
This study is currently recruiting participants.
Verified by Amgen, March 2009
First Received: March 20, 2009   No Changes Posted
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00867100
  Purpose

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).


Condition Intervention Phase
Psoriasis
Drug: AMG 827
Phase I

MedlinePlus related topics: Psoriasis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety & tolerability: AE's, clinically significant changes in safety labs, PE, vital signs, and development of anti-AMG 827 antibodies [ Time Frame: 9-12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of AMG 827 following single dose SC or IV administration in healthy subjects and subjects with moderate to severe PsO. [ Time Frame: 9-12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: December 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: AMG 827
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part A:

  • Able to provide written informed consent
  • Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
  • Additional inclusion criteria apply

Part B:

  • 18 - 55 years old inclusive at 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

Exclusion Criteria:

Part A:

  • History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
  • Additional exclusion criteria apply

Part B:

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
  • Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
  • Additional exclusion criteria apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867100

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
Australia
Research Site Recruiting
Melbourne, Australia
Australia, South Australia
Research Site Recruiting
Adelaide, South Australia, Australia
Canada, Ontario
Research Site Recruiting
Waterloo, Ontario, Canada
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20060279
Study First Received: March 20, 2009
Last Updated: March 20, 2009
ClinicalTrials.gov Identifier: NCT00867100     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Canada: Health Canada;   United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Healthy
Skin Diseases, Papulosquamous

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

ClinicalTrials.gov processed this record on May 07, 2009