NCT05283681

A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Risankizumab	Subcutaneous Injection via Prefilled Syringe (PFS)
DRUG	Risankizumab	Subcutaneous Injection via Auto-Injector (AI)

Timeline

• Start date: 2019-04-02
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study