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New shot delivery method tested in healthy men

NCT ID NCT06951828

Knowledge-focused Sponsor: Celltrion Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two different devices for giving a single dose of the biologic drug CT-P43: an auto-injector and a pre-filled syringe. It involved 162 healthy men aged 19 to 55. The goal was to see if the two methods deliver the drug similarly into the body and to check for any safety issues.

What this could mean

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

Active substance
CT-P43 (a biologic drug given as a shot under the skin)
What this could lead to
If successful, this could show that the auto-injector works as well as the pre-filled syringe, making it easier for patients to give themselves the medicine.
What could go wrong
This is an early-phase trial in healthy men, not patients. It only checks how the body handles the drug and basic safety, not whether it treats 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

162 people

The number who actually took part.

Started

May 2025

Finished

Dec 2025

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

19 to 55 years

Sex

Male participants only

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: * Healthy male subjects, between the ages of 19 and 55 years, both inclusive. * Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.5 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth. Exclusion Criteria: * A medical history and/or condition that is considered significant * Clinically significant allergic reactions, hypersensitivity * History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis * Active or latent Tuberculosis * History of malignancy * Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23

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As listed by the trial registrant

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

Healthy male subjects

Contacts and locations

Locations

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308, South Korea

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