Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05274100

M19-128

Details and patient eligibility

About

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Enrollment: 394 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion criteria

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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394 participants in 5 patient groups

Group 1: Risankizumab Dose A

Experimental group

Description:

Participants will receive risankizumab dose A.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Drug: Risankizumab

Group 2: Risankizumab Dose B

Experimental group

Description:

Participants will receive risankizumab dose B.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Drug: Risankizumab

Group 3: Risankizumab Dose C

Experimental group

Description:

Participants will receive risankizumab dose C.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Drug: Risankizumab

Group 4: Risankizumab Dose D

Experimental group

Description:

Participants will receive risankizumab dose D.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Drug: Risankizumab

Group 5: Risankizumab Dose D

Experimental group

Description:

Participants will receive risankizumab dose D.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Drug: Risankizumab