Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

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

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2023-04-20

Brief Summary

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This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

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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 subcutaneous dose of risankizumab dose A.

Group Type EXPERIMENTAL

Risankizumab Dose A

Intervention Type DRUG

Prefilled Syringe

Risankizumab Dose B

Participants will receive subcutaneous dose of risankizumab dose B.

Group Type EXPERIMENTAL

Risankizumab Dose B

Intervention Type DRUG

Prefilled Syringe

Interventions

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Risankizumab Dose A

Prefilled Syringe

Intervention Type DRUG

Risankizumab Dose B

Prefilled Syringe

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.

Exclusion Criteria

* Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
* Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes