Recruiting
Phase 1

Risankizumab vs. Risankizumab

Sponsor:

AbbVie

Code:

NCT07466550

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Risankizumab

Risankizumab

Study Details

Brief 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.

Conditions

Healthy Volunteer

Study ID

NCT07466550

Start date

Jun 4, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Risankizumab Dose A

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

experimental: Risankizumab Dose B

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

Interventions

Risankizumab

Intravenous (IV)

Risankizumab

Subcutaneous (SC) Injections

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately 155 Days ]
  • Maximum Observed Serum Concentration (Cmax) of Risankizumab [ Time Frame: Up to Approximately 155 Days ]
  • Time to Cmax (Tmax) of Risankizumab [ Time Frame: Up to Approximately 155 Days ]
  • Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab [ Time Frame: Up to Approximately 155 Days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

CenExel ACT- Anaheim Clinical Trials /ID# 281821

Recruiting

Anaheim, California, United States, 92801

Cpmi /Id# 281783

Recruiting

Miami, Florida, United States, 33172

More Information

Sponsor

AbbVie

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Healthy Volunteer
  • Risankizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-01.