A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06937619

M24-920

Details and patient eligibility

About

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

Enrollment: 263 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight greater than 40 kg and less than 100 kg at 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-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
• Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

Risankizumab Arm A

Experimental group

Description:

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.

Treatment:

Drug: Risankizumab

Risankizumab Arm B

Experimental group

Description:

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.

Treatment:

Drug: Risankizumab