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Risankizumab Manufacturing Comparison for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight less than 100.00 kg at Screening and upon initial confinement.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 141
Awards & highlights

Summary

This trial tests if a new drug manufacturing process improves the effectiveness of a drug for treating autoimmune diseases.

Who is the study for?
This trial is for healthy adults who weigh less than 100 kg and have a BMI between 18.0 to 32.0 kg/m2. Participants must pass a medical exam, including vital signs, lab tests, and an ECG to confirm good health.Check my eligibility
What is being tested?
The study aims to compare the bioavailability of Risankizumab when made by two different manufacturing processes in healthy individuals after intravenous infusion.See study design
What are the potential side effects?
As Risankizumab is being tested on healthy subjects, potential side effects may include allergic reactions, injection site reactions, headaches, fatigue or nausea but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is under 100 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 141
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 141 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from Time 0 to Infinity (AUC0-inf)
Apparent Terminal Phase Elimination Rate Constant (β)
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
+4 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475
11%
COVID-19
3%
NASOPHARYNGITIS
3%
HEADACHE
3%
UPPER RESPIRATORY TRACT INFECTION
2%
HYPERTENSION
1%
NASAL INFLAMMATION
1%
DIARRHOEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period A: RZB
Period B: APR/RZB
Period A: APR
Period B: APR/APR
Period B: APR/APR/RZB
Period B: RZB/RZB

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Participants will receive risankizumab manufactured with using the current process (CMC2).
Group II: Arm 2Active Control1 Intervention
Participants will receive risankizumab manufactured with using the new process (CMC3).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 4
~3190

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for conditions studied in healthy subjects, such as IL-23 inhibitors like Risankizumab, work by targeting specific cytokines involved in inflammatory processes. IL-23 inhibitors block the action of interleukin-23, a cytokine that plays a crucial role in the inflammatory response and the maintenance of certain immune-mediated diseases. This inhibition helps reduce inflammation and modulate the immune system. For healthy subjects, understanding these mechanisms is important as it provides insights into the safety, efficacy, and potential side effects of these treatments, ensuring that they can be safely administered and monitored in clinical settings.
Role of inflammatory cytokines in depression: Focus on interleukin-1β.IL-23 Blockade for Crohn s disease: next generation of anti-cytokine therapy.Cancer cachexia update in head and neck cancer: Pathophysiology and treatment.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
983 Previous Clinical Trials
509,313 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,844 Total Patients Enrolled
~29 spots leftby Jul 2025