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New injector tested for arthritis drug in healthy volunteers

NCT ID NCT07007091

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested how well risankizumab enters the body when given through an on-body injector compared to a standard prefilled syringe. 260 healthy volunteers received the drug by one of the two methods. Researchers measured drug levels in the blood and checked for side effects to see if the injector works as well as the syringe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Risankizumab
What this could lead to
If successful, this could lead to a more convenient way to give risankizumab using an on-body injector instead of a syringe.
What could go wrong
This is an early-phase study in healthy people, not patients. It only checks how the drug moves through the body and basic safety, not whether it works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

260 people

The number who actually took part.

Started

Jun 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * 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: * Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening. * Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Acpru /Id# 276043

    Grayslake, Illinois, 60030, United States

  • Cpmi /Id# 276490

    Miami, Florida, 33172, United States

  • PPD Phase I Clinic /ID# 276525

    Austin, Texas, 78744, United States

  • Ppd - Las Vegas Research Unit /ID# 276565

    Las Vegas, Nevada, 89113, United States

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