Clinical trial NCT05567029: Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Approximately up to 113 days
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Approximately up to 113 days
measure: Apparent Terminal Phase Elimination Rate Constant (β)
timeFrame: Approximately up to 113 days
measure: The Terminal Phase Elimination Half-Life (t1/2)
timeFrame: Approximately up to 113 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Approximately up to 113 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
timeFrame: Approximately up to 113 days
measure: Number of Participants with Adverse Events
timeFrame: Approximately up to 140 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 250098
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 250099
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 249681
state: Illinois
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC /ID# 250181
state: Missouri
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 250672
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: