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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: AbGn168 intravenous infusion; Drug: AbGn168 subcutaneous injection

• Registration Number: NCT00848055
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2010-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
arm 2	AbGn168 intravenous infusion	AbGn168 cohort 2
arm 1	AbGn168 intravenous infusion	AbGn168 cohort 1
arm 3	AbGn168 intravenous infusion	AbGn168 cohort 3
arm 4	AbGn168 intravenous infusion	AbGn168 cohort 4
arm 5	AbGn168 intravenous infusion	AbGn168 cohort 5
arm 6	AbGn168 intravenous infusion	AbGn168 cohort 6
arm 7	AbGn168 intravenous infusion	AbGn168 cohort 7
arm 8	AbGn168 subcutaneous injection	AbGn168 cohort 8

Primary Outcome Measures

Name	Time	Method
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events	Baseline, on treatment,and at end of study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy	Baseline and on treatment

Trial Locations

Locations (7)

1240.1.05 Boehringer Ingelheim Investigational Site; 🇺🇸 Boise, Idaho, United States

1240.1.03 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1240.1.04 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

1240.1.02 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

1240.1.7 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1240.1.06 Boehringer Ingelheim Investigational Site; 🇺🇸 Evansville, Indiana, United States

1240.1.01 Boehringer Ingelheim Investigational Site; 🇺🇸 New York, New York, United States