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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848055
• Other study ID #: 1240.1
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2009
• Last updated: October 31, 2013
• Start date: December 2008

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 intravenous infusion
single dose intravenous infusion
• AbGn168 subcutaneous injection
single dose subcutaneous injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events		Baseline, on treatment,and at end of study	No
Secondary	Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy		Baseline and on treatment	No