A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants

A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07466550

Enrollment

Registered

2026-03-12

Start date

2026-06-04

Completion date

2027-01-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, Risankizumab

Brief summary

The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.

Interventions

DRUGRisankizumab

Intravenous (IV)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement. * BMI is ≥ 18.0 to ≤ 32.0 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. * 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

* 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 subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events (AEs)	Up to Approximately 155 Days	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of Risankizumab	Up to Approximately 155 Days	Cmax of Risankizumab.
Time to Cmax (Tmax) of Risankizumab	Up to Approximately 155 Days	Tmax of Risankizumab.
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab	Up to Approximately 155 Days	AUCt of Risankizumab.

Countries

United States

Contacts

CONTACTABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com844-663-3742

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026