A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571266

M24-342

Details and patient eligibility

About

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Enrollment: 231 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
• Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
• 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

• Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
• Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 3 patient groups

Risankizumab Formulation 1

Experimental group

Description:

Participants will receive a single dose of Risankizumab formulation 1 on day 1.

Treatment:

Drug: Risankizumab

Risankizumab Formulation 2

Experimental group

Description:

Participants will receive a single dose of Risankizumab formulation 2 on day 1.

Treatment:

Drug: Risankizumab

Risankizumab Formulation 3

Experimental group

Description:

Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Treatment:

Drug: Risankizumab