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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT05283681
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2022-03
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Male and female healthy volunteers between 18 and 55 years of age.
• Body weight less than 110.00 kg inclusive at Screening.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risankizumab Dose A	Risankizumab	Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days
Risankizumab Dose B	Risankizumab	Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days
Risankizumab Dose C	Risankizumab	Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 140 Days	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.
Maximum observed serum concentration (Cmax)	Up to 113 Days	Maximum observed serum concentration
Time to Cmax (Tmax)	Up to 113 Days	Time to Cmax
Terminal phase elimination rate constant (β)	Up to 113 Days	Terminal phase elimination rate constant
Terminal phase elimination half-life (t1/2)	Up to 113 Days	Terminal phase elimination half-life
Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)	Up to 113 Days	AUC from 0 to time of last measurable concentration
AUC from time 0 to infinity (AUCinf)	Up to 113 Days	AUC from time 0 to infinity
Number of Anti-drug antibody (ADA) Titers	Up to 113 Days	Incidence of anti-drug antibodies

Trial Locations

Locations (2)

Acpru /Id# 210844; 🇺🇸 Grayslake, Illinois, United States

PPD Clinical Research Unit - Austin /ID# 211456; 🇺🇸 Austin, Texas, United States