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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: AbGn168 subcutaneous injection; Drug: AbGn168 intravenous infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848055

1240.1

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

40 participants in 8 patient groups

arm 1

Experimental group

Description:

AbGn168 cohort 1

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 2

Experimental group

Description:

AbGn168 cohort 2

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 3

Experimental group

Description:

AbGn168 cohort 3

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 4

Experimental group

Description:

AbGn168 cohort 4

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 5

Experimental group

Description:

AbGn168 cohort 5

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 6

Experimental group

Description:

AbGn168 cohort 6

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 7

Experimental group

Description:

AbGn168 cohort 7

Treatment:

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

Drug: AbGn168 intravenous infusion

arm 8

Experimental group

Description:

AbGn168 cohort 8

Treatment:

Drug: AbGn168 subcutaneous injection