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OpenTrials
Completed

NCT Number: NCT07007091

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

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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

Cpmi /Id# 276490, Miami, Florida, 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 Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • Body weight between 40 kg and 100 kg, inclusive, at the time of screening.
  • 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

  • Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
  • Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Treatment and study plan

Risankizumab

Drug

Subcutaneous (SC) Injection

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Risankizumab

    Time frame: Up to Approximately 113 days

    Maximum observed plasma concentration (Cmax) of Risankizumab

  2. Time to Cmax (Tmax) of Risankizumab

    Time frame: Up to Approximately 113 days

    Tmax of Risankizumab

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

    Time frame: Up to Approximately 113 days

    Apparent terminal phase elimination rate constant (β) of Risankizumab

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

    Time frame: Up to Approximately 113 days

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

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

    Time frame: Up to Approximately 113 days

    AUCt of Risankizumab

  6. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab

    Time frame: Up to Approximately 113 days

    AUCinf of Risankizumab

  7. Number of Anti-drug antibodies (ADA)

    Time frame: Up to Approximately 113 days

    Incidence of anti-drug antibodies

  8. Number of Participants Experiencing Adverse Events

    Time frame: Up to Approximately 113 days

    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jan 27, 2026

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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