A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06054425

Enrollment

Registered

2023-09-26

Start date

2023-11-20

Completion date

2024-05-06

Last updated

2024-05-14

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

Conditions

Healthy Volunteers

Keywords

Risankizumab

Brief summary

The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).

Interventions

DRUGRisankizumab

Infusion; intravenous

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 Mass Index (BMI) \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at the time of 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 electrocardiogram (ECG). * Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion criteria

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. * Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Serum Concentration (Cmax)	Up to Day 131	Cmax will be assessed.
Time to Cmax (Tmax)	Up to Day 131	Tmax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β)	Up to Day 131	Apparent terminal phase elimination rate constant (β) will be assessed.
Terminal Phase Elimination Half-life (t1/2)	Up to Day 131	Terminal phase elimination half-life (t1/2) will be assessed.
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)	Up to Day 131	AUC0-t will be assessed.
AUC from Time 0 to Infinity (AUC0-inf)	Up to Day 131	AUC0-inf will be assessed.
Number of Participants with Adverse Events (AEs)	Baseline to Day 141	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.

Countries

United States

Outcome results

None listed

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