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Monoclonal Antibodies

Risankizumab Dose A 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 140 days
Awards & highlights

Study Summary

This trial will assess the safety of risankizumab and how it moves through the body. 198 adults will be enrolled and receive the drug through injections. They will be monitored for 10 days and followed up for 140 days to assess for any adverse events.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Terminal Phase Elimination Rate Constant (β)
Maximum Observed Plasma Concentration (Cmax)
Number of Participants with Adverse Events
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Risankizumab Dose BExperimental Treatment1 Intervention
Participants will receive subcutaneous dose of risankizumab dose B.
Group II: Risankizumab Dose AExperimental Treatment1 Intervention
Participants will receive subcutaneous dose of risankizumab dose A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab Dose A
2022
Completed Phase 1
~200
Risankizumab Dose B
2022
Completed Phase 1
~200

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
496,274 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,955 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA given permission for Risankizumab Dose B to be utilized?

"According to our internal assessment, Risankizumab Dose B received a score of 1 given the preliminary nature of this Phase 1 trial and the lack of available data concerning its efficacy or safety."

Answered by AI

Are there currently opportunities for volunteers to join the clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial in question is currently seeking participants - it was initially posted on September 28th 2022 and last updated November 7th 2022. At present, 198 patients are needed from 6 different sites for enrolment into this study."

Answered by AI

For what type of candidate is this trial most suitable?

"This medical trial is attempting to enroll 198 eligible participants, between the ages of 18 and 60 who are deemed healthy. To qualify for this study, applicants must have a body weight which falls within the range of 40-100 kilograms at both screening and upon initial confinement."

Answered by AI

What is the total sample size of this clinical research?

"Affirmative. Supporting information on clinicaltrials.gov reveals that this medical investigation, which was initially published on September 28th 2022, is currently recruiting participants. Approximately 198 patients must be enrolled from 6 distinct healthcare centres."

Answered by AI

Is this research experiment being conducted in numerous healthcare facilities across the United States?

"Anaheim Clinical Trials LLC /ID# 250098 in Anaheim, California, Altasciences /ID# 249628 in Mont-Royal, Quebec and Bio-Kinetic Clinical Applications, LLC /ID# 250181 in Springfield. Missouri serve as three of the nine recruitment sites for this trial."

Answered by AI

Does the current protocol of this medical experiment accept participants aged 55 or over?

"This medical study is searching for volunteers aged eighteen and above, but under sixty years old."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Clinical Pharmacology of Miami /ID# 250099
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Pharmacology of Miami /ID# 250099: < 24 hours
Average response time
  • < 1 Day
~79 spots leftby Mar 2025