A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283681
• Other study ID #: M15-990
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2019
• Est. completion date: November 11, 2019

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male and female healthy volunteers between 18 and 55 years of age.

• Body weight less than 110.00 kg inclusive at Screening.

Exclusion Criteria:

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

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Subcutaneous Injection via Prefilled Syringe (PFS)
• Risankizumab
Subcutaneous Injection via Auto-Injector (AI)

Locations

Country	Name	City	State
United States	PPD Clinical Research Unit - Austin /ID# 211456	Austin	Texas
United States	Acpru /Id# 210844	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.	Up to 140 Days
Primary	Maximum observed serum concentration (Cmax)	Maximum observed serum concentration	Up to 113 Days
Primary	Time to Cmax (Tmax)	Time to Cmax	Up to 113 Days
Primary	Terminal phase elimination rate constant (ß)	Terminal phase elimination rate constant	Up to 113 Days
Primary	Terminal phase elimination half-life (t1/2)	Terminal phase elimination half-life	Up to 113 Days
Primary	Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)	AUC from 0 to time of last measurable concentration	Up to 113 Days
Primary	AUC from time 0 to infinity (AUCinf)	AUC from time 0 to infinity	Up to 113 Days
Primary	Number of Anti-drug antibody (ADA) Titers	Incidence of anti-drug antibodies	Up to 113 Days