A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

NCT ID: NCT06946524

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-08

Study Completion Date

2025-11-25

Brief Summary

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This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Healthy Volunteers Risankizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Risankizumab Arm A

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection

Risankizumab Arm B

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection

Interventions

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Risankizumab

Subcutaneous Injection

Intervention Type DRUG

Other Intervention Names

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SKYRIZI

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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 participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Altasciences Clinical Los Angeles /ID# 276446

Cypress, California, United States

Site Status

Acpru /Id# 275116

Grayslake, Illinois, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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M25-681

Identifier Type: -

Identifier Source: org_study_id