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

A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06487572

Enrollment

Registered

2024-07-05

Start date

2024-07-23

Completion date

2025-02-07

Last updated

2025-02-18

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, Risankizumab, ABBV-066

Brief summary

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

Interventions

DRUGRisankizumab

Intravenous (IV) Infusion

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 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 particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Experiencing Adverse Events	Up to approximately 140 days	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.
Maximum Observed Serum Concentration (Cmax) of Risankizumab	Up to approximately 140 days	Cmax of Risankizumab.
Time to Cmax (Tmax) of Risankizumab	Up to approximately 140 days	Tmax of Risankizumab.
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab	Up to approximately Week 4	AUCt of Risankizumab.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026