Assessing how well risankizumab works when given with an on-body injector to healthy adults
A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector
This study tests how well a new way of giving a medication called risankizumab works in healthy adults to see how effectively the body absorbs it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | risankizumab |
| Locations | 4 sites (Anaheim, California and 3 other locations) |
| Trial ID | NCT06937619 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics and relative bioavailability of risankizumab, a medication administered subcutaneously using an on-body injector, in healthy adult participants. The trial aims to determine how effectively the drug is absorbed and utilized in the body. Participants will be screened for general health and specific eligibility criteria, including BMI and weight parameters. The study is designed to gather data that could inform future treatments using this delivery method.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18.0 and 32.0 kg/m².
Not a fit: Patients who have previously received anti-interleukin-12/23 or anti-interleukin-23 treatments within the last year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of risankizumab's delivery and effectiveness, potentially leading to improved treatment options for patients requiring this medication.
How similar studies have performed: While this specific approach is novel, similar studies assessing bioavailability of medications have shown promise in optimizing drug delivery methods.
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. 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. * 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
Anaheim, California and 3 other locations
- CenExel ACT- Anaheim Clinical Trials /ID# 274805 — Anaheim, California, United States (Recruiting)
- Collaborative Neuroscience Research CNS /ID# 275212 — Los Alamitos, California, United States (Recruiting)
- Cpmi /Id# 274464 — Miami, Florida, United States (Recruiting)
- Acpru /Id# 271954 — Grayslake, Illinois, 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.