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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848055
First Posted: February 20, 2009
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis

Condition Intervention Phase
Psoriasis Drug: AbGn168 intravenous infusion Drug: AbGn168 subcutaneous injection Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion (1 Mcg/kg, 5 Mcg/kg, 25 Mcg/kg, 125 Mcg/kg, 625 Mcg/kg, 3 mg/kg, or 10 mg/kg) or Subcutaneous Injection (625 Mcg/kg) to Patients With Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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 ]

Enrollment: 40
Study Start Date: December 2008
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1
AbGn168 cohort 1
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 2
AbGn168 cohort 2
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 3
AbGn168 cohort 3
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 4
AbGn168 cohort 4
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 5
AbGn168 cohort 5
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 6
AbGn168 cohort 6
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 7
AbGn168 cohort 7
Drug: AbGn168 intravenous infusion
single dose intravenous infusion
Experimental: arm 8
AbGn168 cohort 8
Drug: AbGn168 subcutaneous injection
single dose subcutaneous injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848055


Locations
United States, Idaho
1240.1.05 Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
United States, Indiana
1240.1.06 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
United States, Maryland
1240.1.04 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
1240.1.02 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, New York
1240.1.01 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, Texas
1240.1.03 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
Germany
1240.1.7 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00848055     History of Changes
Other Study ID Numbers: 1240.1
First Submitted: February 18, 2009
First Posted: February 20, 2009
Last Update Posted: November 1, 2013
Last Verified: October 2013

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