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

NCT ID: NCT00848055

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arm 1

AbGn168 cohort 1

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 2

AbGn168 cohort 2

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 3

AbGn168 cohort 3

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 4

AbGn168 cohort 4

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 5

AbGn168 cohort 5

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 6

AbGn168 cohort 6

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 7

AbGn168 cohort 7

Group Type EXPERIMENTAL

AbGn168 intravenous infusion

Intervention Type DRUG

single dose intravenous infusion

arm 8

AbGn168 cohort 8

Group Type EXPERIMENTAL

AbGn168 subcutaneous injection

Intervention Type DRUG

single dose subcutaneous injection

Interventions

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AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 intravenous infusion

single dose intravenous infusion

Intervention Type DRUG

AbGn168 subcutaneous injection

single dose subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1240.1.05 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

Site Status

1240.1.06 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Site Status

1240.1.04 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1240.1.02 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

1240.1.01 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1240.1.03 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1240.1.7 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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1240.1

Identifier Type: -

Identifier Source: org_study_id