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

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2025-04-16

Brief Summary

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This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

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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 Formulation 1

Participants will receive a single dose of Risankizumab formulation 1 on day 1.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

• Subcutaneous Injection via prefilled syringe

Risankizumab Formulation 2

Participants will receive a single dose of Risankizumab formulation 2 on day 1.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

• Subcutaneous Injection via prefilled syringe

Risankizumab Formulation 3

Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

• Subcutaneous Injection via prefilled syringe

Interventions

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Risankizumab

• Subcutaneous Injection via prefilled syringe

Intervention Type DRUG

Other Intervention Names

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ABBV-066 SKYRIZI

Eligibility Criteria

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Inclusion Criteria

* Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
* Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
* 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

* Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
* Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes