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

October 31, 2013 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • 1240.1.7 Boehringer Ingelheim Investigational Site
  • United States
    • Idaho
      • Boise, Idaho, United States
        • 1240.1.05 Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • 1240.1.06 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1240.1.04 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1240.1.02 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1240.1.01 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1240.1.03 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (ESTIMATE)

February 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1240.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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