Risankizumab Dose A for Healthy Subjects

Altasciences /ID# 249628, Mont-Royal, Canada
Healthy SubjectsRisankizumab Dose A - Drug
18 - 60
All Sexes

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

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Approximately up to 140 days

Day 113
Apparent Terminal Phase Elimination Rate Constant (β)
Maximum Observed Plasma Concentration (Cmax)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
The Terminal Phase Elimination Half-Life (t1/2)
Time to Maximum Observed Plasma Concentration (Tmax)
Day 140
Number of Participants with Adverse Events

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Risankizumab Dose A
Experimental Group · 1 Intervention: Risankizumab Dose A · Intervention Types: Drug
Risankizumab Dose B
Experimental Group · 1 Intervention: Risankizumab Dose B · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab Dose A
Completed Phase 1
Risankizumab Dose B
Completed Phase 1

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately up to 140 days

Who is running the clinical trial?

AbbVieLead Sponsor
873 Previous Clinical Trials
479,812 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
325 Previous Clinical Trials
125,004 Total Patients Enrolled

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?
How old are they?
18 - 65100.0%
What site did they apply to?
Clinical Pharmacology of Miami /ID# 250099100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.