Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, August 2009

First Received: February 18, 2009 Last Updated: August 20, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00848055

Purpose

The general aim of the trial is to determine the safety and pharmacologic profile of single doses of AbGn-168 administered intravenously to patients with chronic plaque psoriasis

Condition	Intervention	Phase
Psoriasis	Drug: AbGn-168	Phase I

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion to Patients With Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events [ Time Frame: Baseline, on treatment,and at end of study ]

Secondary Outcome Measures:

Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy [ Time Frame: Baseline and on treatment ]

Estimated Enrollment:	54
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.

Exclusion Criteria:

Recent use of biologic agents, oral psoriasis medications or phototherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848055

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Locations

United States, Idaho
1240.1.05 Boehringer Ingelheim Investigational Site	Terminated
Boise, Idaho, United States
United States, Indiana
1240.1.06 Boehringer Ingelheim Investigational Site	Recruiting
Evansville, Indiana, United States
United States, Maryland
1240.1.04 Boehringer Ingelheim Investigational Site	Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
1240.1.02 Boehringer Ingelheim Investigational Site	Active, not recruiting
Boston, Massachusetts, United States
United States, New York
1240.1.01 Boehringer Ingelheim Investigational Site	Recruiting
New York, New York, United States
United States, Texas
1240.1.03 Boehringer Ingelheim Investigational Site	Not yet recruiting
Dallas, Texas, United States

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1240.1
Study First Received:	February 18, 2009
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00848055 History of Changes
Health Authority:	Germany:; United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 30, 2009