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

NCT05283681 | Completed Phase 1 FDA Drug

• 1 other identifier: M15-990
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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

• Maximum observed serum concentration (Cmax)

  Maximum observed serum concentration

  Up to 113 Days

• Time to Cmax (Tmax)

  Time to Cmax

  Up to 113 Days

• Terminal phase elimination rate constant (β)

  Terminal phase elimination rate constant

  Up to 113 Days

• Terminal phase elimination half-life (t1/2)

  Terminal phase elimination half-life

  Up to 113 Days

• 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

• AUC from time 0 to infinity (AUCinf)

  AUC from time 0 to infinity

  Up to 113 Days

• Number of Anti-drug antibody (ADA) Titers

  Incidence of anti-drug antibodies

  Up to 113 Days

Study Arms (3)

Risankizumab Dose A

EXPERIMENTAL

Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days

Drug: Risankizumab

Risankizumab Dose B

EXPERIMENTAL

Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days

Drug: Risankizumab

Risankizumab Dose C

EXPERIMENTAL

Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous Injection via Prefilled Syringe (PFS)

Also known as: ABBV-066, SKYRIZI

Risankizumab Dose A; Risankizumab Dose B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Acpru /Id# 210844

Grayslake, Illinois, 60030, United States

Location

PPD Clinical Research Unit - Austin /ID# 211456

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: April 2, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)