Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00848055
First received: February 18, 2009
Last updated: June 1, 2011
Last verified: June 2011
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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: 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 to Patients With Chronic Plaque Psoriasis |
Resource links provided by NLM:
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 ] [ 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
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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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: | June 1, 2011 |
| 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 May 16, 2013