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CompletedNCT07007091Updated Jan 27, 2026

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

A Phase 1 interventional study of Risankizumab and Risankizumab in Healthy Volunteers, 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 2026-01-27.

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

Phase
Phase 1
Study type
Interventional
Enrollment
260
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 administration with an on-body injector relative to a prefilled syringe

02

Conditions studied

  • Healthy Volunteers
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) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • Body weight between 40 kg and 100 kg, inclusive, at the time of 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 (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
  • Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.
05

Study design

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

Study arms

  • Experimental
    Arm 1: Risankizumab Prefilled Syringe (PFS)

    Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1

    Drug: Risankizumab

  • Experimental
    Arm 2: Risankizumab On-Body Injector (OBI)

    Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

    Drug: Risankizumab

Interventions

  • DrugRisankizumab

    Subcutaneous (SC) Injection

  • DrugRisankizumab

    On-Body Injector (OBI)

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 113 days

  2. Time to Cmax (Tmax) of Risankizumab

    Tmax of Risankizumab

    Time frame: Up to Approximately 113 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 113 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 113 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 113 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 113 days

  7. Number of Anti-drug antibodies (ADA)

    Incidence of anti-drug antibodies

    Time frame: Up to Approximately 113 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 113 days

07

Study locations

4 sites
  • Cpmi /Id# 276490
    Miami, Florida 33172, United States
  • Acpru /Id# 276043
    Grayslake, Illinois 60030, United States
  • Ppd - Las Vegas Research Unit /ID# 276565
    Las Vegas, Nevada 89113, United States
  • PPD Phase I Clinic /ID# 276525
    Austin, Texas 78744, 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 Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07007091
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Jun 12, 2025
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026
Last update
Jan 27, 2026

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 Jan 2026. You cannot join it, but the record below documents what was studied.

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