COMPLETED

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

Official Title

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

Quick Facts

Study Start:2025-06-12

Study Completion:2026-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07007091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight between 40 kg and 100 kg, inclusive, at the time of screening. * 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.	* Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening. * Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Inclusion Criteria

Exclusion Criteria

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight between 40 kg and 100 kg, inclusive, at the time of screening.
* 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.

* Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
* Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Contacts and Locations

Principal Investigator

ABBVIE INC.

STUDY_DIRECTOR

AbbVie

Study Locations (Sites)

Cpmi /Id# 276490

Miami, Florida, 33172

United States

Acpru /Id# 276043

Grayslake, Illinois, 60030

United States

Ppd - Las Vegas Research Unit /ID# 276565

Las Vegas, Nevada, 89113

United States

PPD Phase I Clinic /ID# 276525

Austin, Texas, 78744

United States

Collaborators and Investigators

Sponsor: AbbVie

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-12

Study Completion Date2026-01-15

Study Record Updates

Study Start Date2025-06-12

Study Completion Date2026-01-15

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers