A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants
NCT ID: NCT07007091
Last Updated: 2025-12-29
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
260 participants
INTERVENTIONAL
2025-06-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1: Risankizumab Prefilled Syringe (PFS)
Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1
Risankizumab
Subcutaneous (SC) Injection
Arm 2: Risankizumab On-Body Injector (OBI)
Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1
Risankizumab
On-Body Injector (OBI)
Interventions
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Risankizumab
Subcutaneous (SC) Injection
Risankizumab
On-Body Injector (OBI)
Eligibility Criteria
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Inclusion Criteria
* Body weight between 40 kg and 100 kg, inclusive, at the time of screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion Criteria
* Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.
18 Years
60 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Cpmi /Id# 276490
Miami, Florida, United States
Acpru /Id# 276043
Grayslake, Illinois, United States
Ppd - Las Vegas Research Unit /ID# 276565
Las Vegas, Nevada, United States
PPD Phase I Clinic /ID# 276525
Austin, Texas, United States
Countries
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Related Links
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Other Identifiers
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M25-814
Identifier Type: -
Identifier Source: org_study_id