NCT05567029

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

A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Risankizumab Dose A	Prefilled Syringe
DRUG	Risankizumab Dose B	Prefilled Syringe

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2022-10-05
• Last updated: 2023-04-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study