A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

NCT06937619

Healthy Volunteer

COMPLETED PHASE1

A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

NCT06946524

Healthy Volunteers

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

NCT06571266

Healthy Volunteers

COMPLETED PHASE1

Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

NCT05274100

Healthy Volunteers

COMPLETED PHASE1

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

NCT07007091

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Risankizumab Dose A

Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Subcutaneous Injection via prepared syringe

Risankizumab Dose B

Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Subcutaneous Injection via syringe pump

Risankizumab Dose C

Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Subcutaneous Injection via syringe pump

Risankizumab Dose D

Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Subcutaneous Injection via prepared syringe

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

risankizumab

Subcutaneous Injection via prepared syringe

Intervention Type DRUG

risankizumab

Subcutaneous Injection via syringe pump

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABBV-066 SKYRIZI ABBV-066 SKYRIZI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion Criteria

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes