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Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

NCT ID: NCT05274100

Last Updated: 2022-03-10

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

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-07-06

Brief Summary

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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).

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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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Group 1: Risankizumab Dose A

Participants will receive risankizumab dose A.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via prefilled syringe (PFS)

Group 2: Risankizumab Dose B

Participants will receive risankizumab dose B.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via on-body delivery system (OBDS)

Group 3: Risankizumab Dose C

Participants will receive risankizumab dose C.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous Injection via on-body delivery system (OBDS)

Group 4: Risankizumab Dose D

Participants will receive risankizumab dose D.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Intravenous Infusion

Group 5: Risankizumab Dose D

Participants will receive risankizumab dose D.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Intravenous Infusion

Interventions

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Risankizumab

Subcutaneous Injection via prefilled syringe (PFS)

Intervention Type DRUG

Risankizumab

Intravenous Infusion

Intervention Type DRUG

Risankizumab

Subcutaneous Injection via on-body delivery system (OBDS)

Intervention Type DRUG

Other Intervention Names

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SKYRIZI SKYRIZI SKYRIZI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Anaheim Clinical Trials LLC /ID# 222821

Anaheim, California, United States

Site Status

Altasciences Clinical Los Angeles, Inc /ID# 222238

Cypress, California, United States

Site Status

Clinical Pharmacology of Miami /ID# 225392

Miami, Florida, United States

Site Status

PPD Clinical Research Unit /ID# 222362

Orlando, Florida, United States

Site Status

Acpru /Id# 222349

Grayslake, Illinois, United States

Site Status

PPD Clinical Research Unit -Las Vegas /ID# 222363

Las Vegas, Nevada, United States

Site Status

PPD Clinical Research Unit - Austin /ID# 222361

Austin, Texas, United States

Site Status

Spaulding Clinical Research LLC /ID# 225405

West Bend, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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M19-128

Identifier Type: -

Identifier Source: org_study_id

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