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Completed

NCT Number: NCT05283694

A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 165737

Grayslake, Illinois, 60030, United States

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 inclusive at Screening and Check-In Day.
  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion criteria

  • Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Treatment and study plan

Risankizumab

Drug

Subcutaneous Injection via prepared syringe

Other names: ABBV-066, SKYRIZI

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 140 Days

    Maximum Observed Plasma Concentration

  2. Time to maximum observed plasma concentration (Tmax)

    Time frame: Up to 140 Days

    Time to maximum observed plasma concentration

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

    Time frame: Up to 140 Days

    AUC from time 0 to the time of last measurable concentration

  4. AUC from time 0 to infinity (AUCinf)

    Time frame: Up to 140 Days

    AUC from time 0 to infinity

  5. Terminal phase elimination rate constant (β)

    Time frame: Up to 140 Days

    Terminal phase elimination rate constant

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

    Time frame: Up to 140 Days

    Terminal phase elimination half-life

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

    Time frame: Up to 140 Days

    Incidence of anti-drug antibodies

  8. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
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.

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