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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AbGn168 intravenous infusion

AbGn168 subcutaneous injection

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

1240.1.05 Boehringer Ingelheim Investigational Site
1240.1.06 Boehringer Ingelheim Investigational Site
1240.1.04 Boehringer Ingelheim Investigational Site
1240.1.02 Boehringer Ingelheim Investigational Site
1240.1.01 Boehringer Ingelheim Investigational Site
1240.1.03 Boehringer Ingelheim Investigational Site
1240.1.7 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

arm 1

arm 2

arm 3

arm 4

arm 5

arm 6

arm 7

arm 8

Arm Description

AbGn168 cohort 1

AbGn168 cohort 2

AbGn168 cohort 3

AbGn168 cohort 4

AbGn168 cohort 5

AbGn168 cohort 6

AbGn168 cohort 7

AbGn168 cohort 8

Outcomes

Primary Outcome Measures

Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests, and adverse events

Secondary Outcome Measures

Pharmacokinetic and pharmacodynamic endpoints including Cmax, tmax, AUC, t1/2, CL and Vss, target lesion assessment and skin biopsy

Full Information

NCT ID

NCT00848055

First Posted

February 18, 2009

Last Updated

October 31, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00848055

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

arm 1

Arm Type

Experimental

Arm Description

AbGn168 cohort 1

Arm Title

arm 2

Arm Type

Experimental

Arm Description

AbGn168 cohort 2

Arm Title

arm 3

Arm Type

Experimental

Arm Description

AbGn168 cohort 3

Arm Title

arm 4

Arm Type

Experimental

Arm Description

AbGn168 cohort 4

Arm Title

arm 5

Arm Type

Experimental

Arm Description

AbGn168 cohort 5

Arm Title

arm 6

Arm Type

Experimental

Arm Description

AbGn168 cohort 6

Arm Title

arm 7

Arm Type

Experimental

Arm Description

AbGn168 cohort 7

Arm Title

arm 8

Arm Type

Experimental

Arm Description

AbGn168 cohort 8

Intervention Type

Drug

Intervention Name(s)

AbGn168 intravenous infusion

Intervention Description