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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

Study 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 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

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 3
~3140

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,999 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,833 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are eligible to enroll in this research project?

"Affirmative. The information posted on clinicaltrials.gov corroborates that this medical trial is actively enrolling participants; it was initially launched on November 20th, 2020 and its parameters were most recently adjusted on November 27th, 2020. To satisfy the demands of the research project, 106 individuals need to be recruited from 3 distinct sites."

Answered by AI

Are there still possibilities for people to join this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this research trial, first posted on November 20th 2023, is currently in search of enrollees. 106 patients need to be recruited from three distinct medical facilities."

Answered by AI

Is senior participation being solicited for this experiment?

"As per the requirements of this medical trial, any prospective participant must be younger than 60 and have attained legal adulthood."

Answered by AI

Has Arm 1 been granted authorization from the Federal Drug Administration?

"Our internal evaluation at Power gave Arm 1 a score of 1, as the clinical trial is in its initial stage and there are few supporting data regarding safety or efficacy."

Answered by AI

What type of individual would best suit the requirements for this clinical trial?

"106 individuals with healthy characteristics aged between 18 and 60 are being accepted into this trial. Notably, the following conditions must be met: a body weight of below 100kg at screening; BMI ranging from 18-32 kg/m2 as determined by rounding to tenths decimal at the time of screening; general good health identified through medical history, physical examination, vital signs analysis and 12-lead ECG."

Answered by AI

Who else is applying?

What site did they apply to?
Anaheim Clinical Trials LLC /ID# 260740
Clinical Pharmacology of Miami /ID# 260800
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
2023. "A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054425.
~30 spots leftby Jul 2024
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