A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).

Official Title
-----------------
A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Risankizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at the time of screening and upon initial confinement. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG). Body weight less than 100.00 kg at Screening and upon initial confinement. Exclusion Criteria: History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Participants will receive risankizumab manufactured with using the current process (CMC2). | Drug: Risankizumab<br>* Infusion; intravenous<br>|
| Active Comparator: Arm 2<br>Participants will receive risankizumab manufactured with using the new process (CMC3). | Drug: Risankizumab<br>* Infusion; intravenous<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) | Cmax will be assessed. | Up to Day 131 | 
| Time to Cmax (Tmax) | Tmax will be assessed. | Up to Day 131 | 
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent terminal phase elimination rate constant (β) will be assessed. | Up to Day 131 | 
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) will be assessed. | Up to Day 131 | 
| Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) | AUC0-t will be assessed. | Up to Day 131 | 
| AUC from Time 0 to Infinity (AUC0-inf) | AUC0-inf will be assessed. | Up to Day 131 | 
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 141 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risankizumab