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

NCT05567029 | Completed Phase 1 FDA Drug

• 1 other identifier: M23-522
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Risankizumab

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Risankizumab Dose A

EXPERIMENTAL

Participants will receive subcutaneous dose of risankizumab dose A.

Drug: Risankizumab Dose A

Risankizumab Dose B

EXPERIMENTAL

Participants will receive subcutaneous dose of risankizumab dose B.

Drug: Risankizumab Dose B

Interventions

Risankizumab Dose A DRUG

Prefilled Syringe

Risankizumab Dose A

Risankizumab Dose B DRUG

Prefilled Syringe

Risankizumab Dose B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (5)

Anaheim Clinical Trials LLC /ID# 250098

Anaheim, California, 92801-2658, United States

Location

Clinical Pharmacology of Miami /ID# 250099

Miami, Florida, 33014, United States

Location

Acpru /Id# 249681

Grayslake, Illinois, 60030, United States

Location

Bio-Kinetic Clinical Applications, LLC /ID# 250181

Springfield, Missouri, 65802, United States

Location

PPD Clinical Research Unit - Austin /ID# 250672

Austin, Texas, 78744, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: September 28, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)