A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: risankizumab; Drug: risankizumab

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 165737

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
• Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion Criteria:

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab Dose A; Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.	Drug: risankizumab; Subcutaneous Injection via prepared syringe; Other Names: ABBV-066; SKYRIZI; Drug: risankizumab; Subcutaneous Injection via syringe pump; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Dose B; Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.	Drug: risankizumab; Subcutaneous Injection via prepared syringe; Other Names: ABBV-066; SKYRIZI; Drug: risankizumab; Subcutaneous Injection via syringe pump; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Dose C; Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.	Drug: risankizumab; Subcutaneous Injection via prepared syringe; Other Names: ABBV-066; SKYRIZI; Drug: risankizumab; Subcutaneous Injection via syringe pump; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Dose D; Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.	Drug: risankizumab; Subcutaneous Injection via prepared syringe; Other Names: ABBV-066; SKYRIZI; Drug: risankizumab; Subcutaneous Injection via syringe pump; Other Names: ABBV-066; SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.	Up to 140 Days
Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration	Up to 140 Days
Time to maximum observed plasma concentration (Tmax)	Time to maximum observed plasma concentration	Up to 140 Days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)	AUC from time 0 to the time of last measurable concentration	Up to 140 Days
AUC from time 0 to infinity (AUCinf)	AUC from time 0 to infinity	Up to 140 Days
Terminal phase elimination rate constant (β)	Terminal phase elimination rate constant	Up to 140 Days
Terminal phase elimination half-life (t1/2).	Terminal phase elimination half-life	Up to 140 Days
Number of Anti-drug antibody (ADA) Titers	Incidence of anti-drug antibodies	Up to 140 Days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): June 12, 2018

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M16-324

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