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Completed

NCT Number: NCT06571266

A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

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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

Cenexel Act /ID# 270310, 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 40 kg to 100 kg, inclusive, at screening and upon initial confinement
  • Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon 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 ECG.

Exclusion criteria

  • Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
  • Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Treatment and study plan

Risankizumab

Drug
  • Subcutaneous Injection via prefilled syringe

Other names: ABBV-066, SKYRIZI

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to day 140

    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.

  2. Maximum Observed Serum Concentration (Cmax) of Risankizumab

    Time frame: Up to Day 140

    Cmax will be assessed of Risankizumab

  3. Time to Cmax (Tmax) of Risankizumab

    Time frame: Up to Day 140

    Tmax will be assessed of Risankizumab

  4. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab

    Time frame: Up to Day 140

    Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab

  5. Terminal Phase Elimination Half-life (t1/2) of Risankizumab

    Time frame: Up to Day 140

    Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab

  6. Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)

    Time frame: Up to Day 140

    AUC0-t will be assessed

  7. AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab

    Time frame: Up to Day 140

    AUC0-inf will be assessed of Risankizumab

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

    Time frame: Up to Day 140

    Incidence and concentration of anti-drug antibodies

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
May 16, 2025

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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