Skip to main content
OpenTrials
Completed

NCT Number: NCT05567029

Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials LLC /ID# 250098, Anaheim, California, 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

  • Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.

Exclusion criteria

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

Treatment and study plan

Risankizumab Dose A

Drug

Prefilled Syringe

Risankizumab Dose B

Drug

Prefilled Syringe

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Approximately up to 113 days

    Maximum Observed Plasma Concentration (Cmax)

  2. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Approximately up to 113 days

    Time to Maximum Observed Plasma Concentration (Tmax)

  3. Apparent Terminal Phase Elimination Rate Constant (β)

    Time frame: Approximately up to 113 days

    Apparent Terminal Phase Elimination Rate Constant (β)

  4. The Terminal Phase Elimination Half-Life (t1/2)

    Time frame: Approximately up to 113 days

    The Terminal Phase Elimination Half-Life (t1/2)

  5. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

    Time frame: Approximately up to 113 days

    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

  6. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)

    Time frame: Approximately up to 113 days

    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)

  7. Number of Participants with Adverse Events

    Time frame: Approximately up to 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Apr 28, 2023

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.