Assessing how well risankizumab is absorbed in healthy adults using different delivery methods
A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to Prefilled Syringe
PHASE1 · AbbVie · NCT06946524
This study is testing how well a new medication called risankizumab is absorbed in healthy adults when given through different delivery methods, like a pen or a syringe.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Drugs / interventions | risankizumab |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT06946524 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics and bioavailability of risankizumab when administered subcutaneously via a prefilled pen compared to a prefilled syringe in healthy adult participants. It aims to determine the safety, tolerability, and immunogenicity of the drug in this population. Healthy volunteers will undergo screening to ensure they meet specific health criteria before participating in the trial. The study will provide insights into the effectiveness of different administration methods for this medication.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.0 and 32.0 kg/m².
Not a fit: Patients with a history of anti-interleukin treatments or those planning strenuous exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the delivery methods of risankizumab, potentially improving patient experience and outcomes.
How similar studies have performed: Other studies have shown success in assessing bioavailability and pharmacokinetics of similar biologic treatments, indicating this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Where this trial is running
Cypress, California
- Altasciences Clinical Los Angeles /ID# 276446 — Cypress, California, United States (RECRUITING)
Study contacts
- Study coordinator: ABBVIE CALL CENTER
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteers, Risankizumab