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RecruitingNCT07466550Updated Jul 1, 2026

A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants

A Phase 1 interventional study of Risankizumab and Risankizumab in Healthy Volunteer, sponsored by AbbVie. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

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

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • Risankizumab
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 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.
  • BMI is ≥ 18.0 to ≤ 32.0 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.
  • 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:

  • 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.
05

Study design

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

Study arms

  • Experimental
    Risankizumab Dose A

    Participants will receive Dose A of risankizumab via intravenous (IV) infusion.

    Drug: Risankizumab

  • Experimental
    Risankizumab Dose B

    Participants will receive Dose B of risankizumab via subcutaneous (SC) injection.

    Drug: Risankizumab

Interventions

  • DrugRisankizumab

    Intravenous (IV)

  • DrugRisankizumab

    Subcutaneous (SC) Injections

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Time frame: Up to Approximately 155 Days

  2. Maximum Observed Serum Concentration (Cmax) of Risankizumab

    Cmax of Risankizumab.

    Time frame: Up to Approximately 155 Days

  3. Time to Cmax (Tmax) of Risankizumab

    Tmax of Risankizumab.

    Time frame: Up to Approximately 155 Days

  4. Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab

    AUCt of Risankizumab.

    Time frame: Up to Approximately 155 Days

07

Study locations

2 of 2 sites recruiting
  • CenExel ACT- Anaheim Clinical Trials /ID# 281821
    Anaheim, California 92801, United States
    Recruiting
  • Cpmi /Id# 281783
    Miami, Florida 33172, United States
    Recruiting
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 Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07466550
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Jun 4, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

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

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