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

• ClinicalTrials.gov Identifier: NCT05567029
• Recruitment Status: Active, not recruiting
• First Posted: October 5, 2022
• Last Update Posted: January 13, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Risankizumab Dose A; Drug: Risankizumab Dose B	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: September 28, 2022
• Estimated Primary Completion Date: May 6, 2023
• Estimated Study Completion Date: May 6, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Approximately up to 113 days ]
   Maximum Observed Plasma Concentration (Cmax)
2. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Approximately up to 113 days ]
   Time to Maximum Observed Plasma Concentration (Tmax)
3. Apparent Terminal Phase Elimination Rate Constant (β) [ Time Frame: Approximately up to 113 days ]
   Apparent Terminal Phase Elimination Rate Constant (β)
4. The Terminal Phase Elimination Half-Life (t1/2) [ Time Frame: Approximately up to 113 days ]
   The Terminal Phase Elimination Half-Life (t1/2)
5. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) [ Time Frame: 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)
6. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) [ Time Frame: Approximately up to 113 days ]
   The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
7. Number of Participants with Adverse Events [ Time Frame: Approximately up to 140 days ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

Anaheim Clinical Trials LLC /ID# 250098

Anaheim, California, United States, 92801-2658

United States, Florida

Clinical Pharmacology of Miami /ID# 250099

Miami, Florida, United States, 33014

United States, Illinois

Acpru /Id# 249681

Grayslake, Illinois, United States, 60030

United States, Missouri

Bio-Kinetic Clinical Applications, LLC /ID# 250181

Springfield, Missouri, United States, 65802-4842

United States, Texas

PPD Clinical Research Unit - Austin /ID# 250672

Austin, Texas, United States, 78744

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05567029
• Other Study ID Numbers: M23-522
• First Posted: October 5, 2022
• Last Update Posted: January 13, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by AbbVie:

Risankizumab

Additional relevant MeSH terms:

Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs