Phase 1: testing Risankizumab for Healthy Volunteer
This study wants to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.
Official registry: https://clinicaltrials.gov/study/NCT07466550 · AbbVie · enrollment listed as 60
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. This study wants to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.
They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab
Interventions: Risankizumab, Risankizumab
Primary outcome (registry wording): Number of Participants with Adverse Events (AEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement
- body-mass index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. body-mass index (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
Who the registry excludes
- 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
Public study contact (from the registry)
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- CenExel ACT- Anaheim Clinical Trials /ID# 281821 — Anaheim, California (recruiting)
- Cpmi /Id# 281783 — Miami, Florida (recruiting)
FAQ about this NCT record
Is NCT07466550 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07466550?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07466550?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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