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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00848055
First received: February 18, 2009
Last updated: October 31, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety Study
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00848055     History of Changes
Other Study ID Numbers: 1240.1
Study First Received: February 18, 2009
Last Updated: October 31, 2013
Health Authority: Germany:
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014