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CompletedNCT06937619Updated Nov 17, 2025

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

A Phase 1 interventional study of Risankizumab in Healthy Volunteer, sponsored by AbbVie. Completed at 4 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
263
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • Risankizumab
  • ABBV-066
  • SKYRIZI
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
263 participants (actual)

Study arms

  • Experimental
    Risankizumab Arm A

    Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.

    Drug: Risankizumab

  • Experimental
    Risankizumab Arm B

    Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.

    Drug: Risankizumab

Interventions

  • DrugRisankizumab

    Subcutaneous Injection

    Also known as: SKYRIZI, ABBV-066

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Risankizumab

    Maximum observed plasma concentration (Cmax) of Risankizumab

    Time frame: Up to approximately 140 days

  2. Time to Cmax (Tmax) of Risankizumab

    Tmax of Risankizumab

    Time frame: Up to approximately 140 days

  3. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab

    Apparent terminal phase elimination rate constant (β) of Risankizumab

    Time frame: Up to approximately 140 days

  4. Terminal Phase Elimination Half-life (t1/2) of Risankizumab

    Terminal phase elimination half-life (t1/2) of Risankizumab

    Time frame: Up to approximately 140 days

  5. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab

    AUCt of Risankizumab

    Time frame: Up to approximately 140 days

  6. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab

    AUCinf of Risankizumab

    Time frame: Up to approximately 140 days

  7. Number of Anti-drug antibody (ADA) Titers

    Incidence and concentration of anti-drug antibodies

    Time frame: Up to approximately 140 days

  8. Number of Participants Experiencing Adverse Events

    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

    Time frame: Up to approximately 140 days

07

Study locations

4 sites
  • CenExel ACT- Anaheim Clinical Trials /ID# 274805
    Anaheim, California 92801, United States
  • Collaborative Neuroscience Research CNS /ID# 275212
    Los Alamitos, California 90720, United States
  • Cpmi /Id# 274464
    Miami, Florida 33172, United States
  • Acpru /Id# 271954
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06937619
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Apr 21, 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025
Last update
Nov 17, 2025

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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