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

• Status: Recruiting
• Trial end date: 2023-05-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

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.