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OpenTrials
Completed

NCT Number: NCT06487572

A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Of Miami /ID# 268219, 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) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • Body weight greater than 40 kg and less than 100 kg at screening and upon initial 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

  • Previous 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 particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Treatment and study plan

Risankizumab

Drug

Intravenous (IV) Infusion

Other names: ABBV-066, SKYRIZI

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 140 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.

  2. Maximum Observed Serum Concentration (Cmax) of Risankizumab

    Time frame: Up to approximately 140 days

    Cmax of Risankizumab.

  3. Time to Cmax (Tmax) of Risankizumab

    Time frame: Up to approximately 140 days

    Tmax of Risankizumab.

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

    Time frame: Up to approximately Week 4

    AUCt of Risankizumab.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Feb 18, 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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