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A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

NCT06937619 — Phase 1, Completed, 263 participants, AbbVie

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A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector

RegistryNCT06937619
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: none, basic science
Enrollment263 (Actual)
SponsorAbbVie (Industry)
ConditionsHealthy Volunteer
InterventionsRisankizumab (Drug)
Datesstart 2025-04-21, primary completion 2025-11-10, completion 2025-11-10, first posted 2025-04-22, last updated 2025-11-17
Locations4 sites in United States

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-Summary

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

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+Arms and interventions

ArmTypeInterventionsDescription
Risankizumab Arm AExperimentalDrug: RisankizumabParticipants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.
Risankizumab Arm BExperimentalDrug: RisankizumabParticipants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.
  • Risankizumab (Drug), also known as SKYRIZI, ABBV-066: Subcutaneous Injection

+Outcome measures

Primary outcomes

  • Maximum Observed Plasma Concentration (Cmax) of Risankizumab [Up to approximately 140 days]: Maximum observed plasma concentration (Cmax) of Risankizumab
  • Time to Cmax (Tmax) of Risankizumab [Up to approximately 140 days]: Tmax of Risankizumab
  • Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab [Up to approximately 140 days]: Apparent terminal phase elimination rate constant (β) of Risankizumab
  • Terminal Phase Elimination Half-life (t1/2) of Risankizumab [Up to approximately 140 days]: Terminal phase elimination half-life (t1/2) of Risankizumab
  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab [Up to approximately 140 days]: AUCt of Risankizumab
  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab [Up to approximately 140 days]: AUCinf of Risankizumab
  • Number of Anti-drug antibody (ADA) Titers [Up to approximately 140 days]: Incidence and concentration of anti-drug antibodies
  • Number of Participants Experiencing Adverse Events [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

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (4)

FacilityCityCountryStatus
CenExel ACT- Anaheim Clinical Trials /ID# 274805Anaheim, CaliforniaUnited States
Collaborative Neuroscience Research CNS /ID# 275212Los Alamitos, CaliforniaUnited States
Cpmi /Id# 274464Miami, FloridaUnited States
Acpru /Id# 271954Grayslake, IllinoisUnited States

+Investigators

  • ABBVIE INC., Study director, AbbVie

My Notes