A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

AbbVie

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007091

M25-814

Details and patient eligibility

About

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight between 40 kg and 100 kg, inclusive, at the time of screening.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion criteria

• Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
• Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Arm 1: Risankizumab Prefilled Syringe (PFS)

Experimental group

Description:

Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Arm 2: Risankizumab On-Body Injector (OBI)

Experimental group

Description:

Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

Treatment:

Drug: Risankizumab

Drug: Risankizumab