Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

AbbVie

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Risankizumab Dose B

Drug: Risankizumab Dose A

Study type

Interventional

Funder types

Industry

Identifiers

NCT05567029

M23-522

Details and patient eligibility

About

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

Enrollment

198 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.

Exclusion criteria

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