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Recruiting NCT07466550

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Risankizumab, Risankizumab.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Risankizumab
    Intravenous (IV)
  • Drug Risankizumab
    Subcutaneous (SC) Injections

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately 155 Days]
  • Maximum Observed Serum Concentration (Cmax) of Risankizumab [Time frame: Up to Approximately 155 Days]
  • Time to Cmax (Tmax) of Risankizumab [Time frame: Up to Approximately 155 Days]
  • Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab [Time frame: Up to Approximately 155 Days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • CenExel ACT- Anaheim Clinical Trials /ID# 281821 — Anaheim
  • Cpmi /Id# 281783 — Miami

Identifiers

NCT: NCT07466550 · M26-134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗