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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Risankizumab Dose A; Drug: Risankizumab Dose B

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801-2658
      • Anaheim Clinical Trials LLC /ID# 250098
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami /ID# 250099
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 249681
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC /ID# 250181
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Clinical Research Unit - Austin /ID# 250672

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab Dose A; Participants will receive subcutaneous dose of risankizumab dose A.	Drug: Risankizumab Dose A; Prefilled Syringe
Experimental: Risankizumab Dose B; Participants will receive subcutaneous dose of risankizumab dose B.	Drug: Risankizumab Dose B; Prefilled Syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax)	Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)	Apparent Terminal Phase Elimination Rate Constant (β)	Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)	The Terminal Phase Elimination Half-Life (t1/2)	Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)	Approximately up to 113 days
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Approximately up to 140 days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Risankizumab
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M23-522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes