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

NCT05283694 | Completed Phase 1 FDA Drug

• 1 other identifier: M16-324
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Study Arms (4)

Risankizumab Dose A

EXPERIMENTAL

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

Risankizumab Dose B

EXPERIMENTAL

Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.

Drug: risankizumab

Risankizumab Dose C

EXPERIMENTAL

Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.

Drug: risankizumab

Risankizumab Dose D

EXPERIMENTAL

Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.

Drug: risankizumab

Interventions

risankizumab DRUG

Subcutaneous Injection via prepared syringe

Also known as: ABBV-066, SKYRIZI

Risankizumab Dose A; Risankizumab Dose D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 165737

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Interventions

risankizumab

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: March 9, 2022
• First Posted: March 17, 2022
• Study Start: September 11, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)