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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567029
• Other study ID #: M23-522
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: April 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab Dose A
Prefilled Syringe
• Risankizumab Dose B
Prefilled Syringe

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 250098	Anaheim	California
United States	PPD Clinical Research Unit - Austin /ID# 250672	Austin	Texas
United States	Acpru /Id# 249681	Grayslake	Illinois
United States	Clinical Pharmacology of Miami /ID# 250099	Miami	Florida
United States	Bio-Kinetic Clinical Applications, LLC /ID# 250181	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	Approximately up to 113 days
Primary	Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax)	Approximately up to 113 days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß)	Apparent Terminal Phase Elimination Rate Constant (ß)	Approximately up to 113 days
Primary	The Terminal Phase Elimination Half-Life (t1/2)	The Terminal Phase Elimination Half-Life (t1/2)	Approximately up to 113 days
Primary	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	Approximately up to 113 days
Primary	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC8)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC8)	Approximately up to 113 days
Primary	Number of Participants with Adverse Events	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. The investigator assesses the relationship of each event to the use of study.	Approximately up to 140 days