Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05274100

Enrollment

394

Registered

2022-03-10

Start date

2020-09-01

Completion date

2021-07-06

Last updated

2022-03-10

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

Conditions

Healthy Volunteers

Keywords

Risankizumab, SKYRIZI

Brief summary

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Interventions

DRUGRisankizumab

Subcutaneous Injection via prefilled syringe (PFS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

\- Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion criteria

\- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Experiencing Adverse Events (AEs)	Up to approximately 140 days	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Serum Concentration (Cmax)	Up to approximately 113 days	Maximum observed serum concentration (Cmax) of risankizumab.
Time to Cmax (Tmax)	Up to approximately 113 days	Time to Cmax of risankizumab.
Apparent Terminal Phase Elimination Rate Constant (β)	Up to approximately 113 days	Apparent terminal phase elimination rate constant (β) of risankizumab.
Terminal Phase Elimination Hhalf-life (t1/2)	Up to approximately 113 days	Terminal phase elimination half-life (t1/2) of risankizumab.
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)	Up to approximately 113 days	AUCt of risankizumab.
AUC From Time 0 to Infinity (AUCinf)	Up to approximately 113 days	AUCinf of risankizumab.

Countries

United States

Outcome results

None listed

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