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OpenTrials
Completed

NCT Number: NCT05274100

Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

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).

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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# 222821, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Risankizumab

Drug

Subcutaneous Injection via prefilled syringe (PFS)

Other names: SKYRIZI

Primary outcomes

  1. Percentage of Participants Experiencing Adverse Events (AEs)

    Time frame: 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.

  2. Maximum Observed Serum Concentration (Cmax)

    Time frame: Up to approximately 113 days

    Maximum observed serum concentration (Cmax) of risankizumab.

  3. Time to Cmax (Tmax)

    Time frame: Up to approximately 113 days

    Time to Cmax of risankizumab.

  4. Apparent Terminal Phase Elimination Rate Constant (β)

    Time frame: Up to approximately 113 days

    Apparent terminal phase elimination rate constant (β) of risankizumab.

  5. Terminal Phase Elimination Hhalf-life (t1/2)

    Time frame: Up to approximately 113 days

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

  6. Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)

    Time frame: Up to approximately 113 days

    AUCt of risankizumab.

  7. AUC From Time 0 to Infinity (AUCinf)

    Time frame: Up to approximately 113 days

    AUCinf of risankizumab.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Mar 10, 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.

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