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

Boehringer Ingelheim40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

AbGn168 intravenous infusionDRUG

single dose intravenous infusion

AbGn168 intravenous infusionDRUG

single dose intravenous infusion

AbGn168 intravenous infusionDRUG

single dose intravenous infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

1240.1.05 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

1240.1.06 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

1240.1.04 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1240.1.02 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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