A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

AbbVie

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Risankizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05283681

M15-990

Details and patient eligibility

About

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Enrollment

226 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female healthy volunteers between 18 and 55 years of age.
Body weight less than 110.00 kg inclusive at Screening.

Exclusion criteria

Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

226 participants in 3 patient groups

Risankizumab Dose A

Experimental group

Description:

Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days

Treatment:

Drug: Risankizumab

Risankizumab Dose B

Experimental group

Description:

Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days

Treatment:

Drug: Risankizumab

Risankizumab Dose C

Experimental group

Description:

Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days.