Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274100
• Other study ID #: M19-128
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: July 6, 2021

Study information

• Verified date: March 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
• Risankizumab
Intravenous Infusion
• Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 222821	Anaheim	California
United States	PPD Clinical Research Unit - Austin /ID# 222361	Austin	Texas
United States	Altasciences Clinical Los Angeles, Inc /ID# 222238	Cypress	California
United States	Acpru /Id# 222349	Grayslake	Illinois
United States	PPD Clinical Research Unit -Las Vegas /ID# 222363	Las Vegas	Nevada
United States	Clinical Pharmacology of Miami /ID# 225392	Miami	Florida
United States	PPD Clinical Research Unit /ID# 222362	Orlando	Florida
United States	Spaulding Clinical Research LLC /ID# 225405	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing 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. The investigator assesses the relationship of each event to the use of study.	Up to approximately 140 days
Primary	Maximum Observed Serum Concentration (Cmax)	Maximum observed serum concentration (Cmax) of risankizumab.	Up to approximately 113 days
Primary	Time to Cmax (Tmax)	Time to Cmax of risankizumab.	Up to approximately 113 days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß)	Apparent terminal phase elimination rate constant (ß) of risankizumab.	Up to approximately 113 days
Primary	Terminal Phase Elimination Hhalf-life (t1/2)	Terminal phase elimination half-life (t1/2) of risankizumab.	Up to approximately 113 days
Primary	Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)	AUCt of risankizumab.	Up to approximately 113 days
Primary	AUC From Time 0 to Infinity (AUCinf)	AUCinf of risankizumab.	Up to approximately 113 days