NCT05567029

Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

Brief summary

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world. All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations. There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

Interventional study

Status:
Recruiting
Conditions:
Healthy Volunteers
Enrollment:
198 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M23-522
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Basic Science

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 60 Years.

Inclusion Criteria:

- Body weight greater than 40 kg and less than 100 kg at screening and upon initial
confinement.

Exclusion Criteria:

- Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.

- Intention to perform strenuous exercise to which the participant is unaccustomed
within one week prior to administration of study drug or during the study.

All the cities where the clinical studies are located

Mont-Royal - H3P 3P1

Quebec