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.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
7 Primary · 0 Secondary · Reporting Duration: Approximately up to 140 days
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Risankizumab Dose A
1 of 2
Risankizumab Dose B
1 of 2
Experimental Treatment
198 Total Participants · 2 Treatment Groups
Primary Treatment: Risankizumab Dose A · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 60 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Clinical Pharmacology of Miami /ID# 250099 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Clinical Pharmacology of Miami /ID# 250099: < 24 hours
Average response time
- < 1 Day
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor