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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2019-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Risankizumab Dose A

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via Prefilled Syringe (PFS)

Risankizumab Dose B

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via Prefilled Syringe (PFS)

Risankizumab Dose C

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via Auto-Injector (AI)

Interventions

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Risankizumab

Subcutaneous Injection via Prefilled Syringe (PFS)

Intervention Type DRUG

Risankizumab

Subcutaneous Injection via Auto-Injector (AI)

Intervention Type DRUG

Other Intervention Names

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ABBV-066 SKYRIZI ABBV-066 SKYRIZI

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes