A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

NCT06487572 | Completed Phase 1

• 1 other identifier: M24-460
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Risankizumab; ABBV-066

Outcome Measures

Primary Outcomes (4)

• Number of Participants Experiencing Adverse Events

  An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  Up to approximately 140 days

• Maximum Observed Serum Concentration (Cmax) of Risankizumab

  Cmax of Risankizumab.

  Up to approximately 140 days

• Time to Cmax (Tmax) of Risankizumab

  Tmax of Risankizumab.

  Up to approximately 140 days

• Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab

  AUCt of Risankizumab.

  Up to approximately Week 4

Study Arms (2)

Risankizumab Dose A for Intravenous (IV) Infusion

EXPERIMENTAL

Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.

Drug: Risankizumab

Risankizumab Dose B for Subcutaneous (SC) Injection

EXPERIMENTAL

Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Intravenous (IV) Infusion

Also known as: ABBV-066, SKYRIZI

Risankizumab Dose A for Intravenous (IV) Infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

You may not qualify if:

• Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
• Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Clinical Pharmacology Of Miami /ID# 268219

Miami, Florida, 33014, United States

Location

Acpru /Id# 267057

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

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: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 23, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)