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NCT Number: NCT07466550

A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants

The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.

Recruiting

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT- Anaheim Clinical Trials /ID# 281821, 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 between 40 kg and 100 kg inclusive at screening and upon initial confinement.
  • BMI is ≥ 18.0 to ≤ 32.0 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.
  • 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

  • Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
  • Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.

Treatment and study plan

Risankizumab

Drug

Intravenous (IV)

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately 155 Days

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is 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 Approximately 155 Days

    Cmax of Risankizumab.

  3. Time to Cmax (Tmax) of Risankizumab

    Time frame: Up to Approximately 155 Days

    Tmax of Risankizumab.

  4. Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab

    Time frame: Up to Approximately 155 Days

    AUCt of Risankizumab.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Jul 1, 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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