Skip to main content
OpenTrials
Completed

NCT Number: NCT05283681

A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 210844, Grayslake, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female healthy volunteers between 18 and 55 years of age.
  • Body weight less than 110.00 kg inclusive at Screening.

Exclusion criteria

  • Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
  • Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

Treatment and study plan

Risankizumab

Drug

Subcutaneous Injection via Prefilled Syringe (PFS)

Other names: ABBV-066, SKYRIZI

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Up to 140 Days

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

  2. Maximum observed serum concentration (Cmax)

    Time frame: Up to 113 Days

    Maximum observed serum concentration

  3. Time to Cmax (Tmax)

    Time frame: Up to 113 Days

    Time to Cmax

  4. Terminal phase elimination rate constant (β)

    Time frame: Up to 113 Days

    Terminal phase elimination rate constant

  5. Terminal phase elimination half-life (t1/2)

    Time frame: Up to 113 Days

    Terminal phase elimination half-life

  6. Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)

    Time frame: Up to 113 Days

    AUC from 0 to time of last measurable concentration

  7. AUC from time 0 to infinity (AUCinf)

    Time frame: Up to 113 Days

    AUC from time 0 to infinity

  8. Number of Anti-drug antibody (ADA) Titers

    Time frame: Up to 113 Days

    Incidence of anti-drug antibodies

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.