← Back to Search

Monoclonal Antibodies

Risankizumab for Healthy Participants

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight must be greater than 40 kg and less than 100 kg at screening and upon initial confinement.
Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 140 days
Awards & highlights

Summary

This trial will compare how the body processes Risankizumab when given through a vein versus under the skin.

Who is the study for?
This trial is for healthy individuals who want to participate in a study comparing two ways of receiving Risankizumab, a medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.
What is being tested?
The focus of this trial is on how the body absorbs Risankizumab when it's given through an IV (intravenous) versus as a shot under the skin (subcutaneous). The goal is to understand differences in drug levels in the bloodstream with these methods.
What are the potential side effects?
As Risankizumab is being administered to healthy participants, side effects may include reactions at the injection site, potential allergic responses, or other immune-related issues. Exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 40 kg and 100 kg.
Select...
My BMI is between 18.0 and 32.0.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 140 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 140 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Number of Participants Experiencing Adverse Events
+1 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475
14%
COVID-19
8%
NASOPHARYNGITIS
4%
HEADACHE
3%
NAUSEA
3%
UPPER RESPIRATORY TRACT INFECTION
1%
DIARRHOEA
1%
CORONARY ARTERY DISEASE
1%
PROSTATE CANCER
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period B: APR/APR
Period A: APR
Period A: RZB
Period B: RZB/RZB
Period B: APR/RZB
Period B: APR/APR/RZB

Trial Design

2Treatment groups
Experimental Treatment
Group I: Risankizumab Dose B for Subcutaneous (SC) InjectionExperimental Treatment1 Intervention
Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.
Group II: Risankizumab Dose A for Intravenous (IV) InfusionExperimental Treatment1 Intervention
Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 4
~3190

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,718 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
156,038 Total Patients Enrolled
~40 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top