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Healthy volunteers help compare new biosimilar to taltz

NCT ID NCT07200986

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new biosimilar medicine (CT-P52) works similarly to the approved drug Taltz in the body. It involves 218 healthy adults aged 19 to 55 who receive a single dose of either the biosimilar or Taltz. The main goal is to compare how the drug is absorbed and its safety, not to treat 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

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

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

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: * Healthy male or female subjects between the ages of 19 to 55 years, both inclusive. * Subject with a body weight of ≥60 and ≤90 kg for male and ≥50 and ≤90 kg for female, and a BMI between 18.0 and 29.9 kg/m2 (both inclusive) when rounded to the nearest tenth. * Subject is able to understand and to comply with protocol requirements, instructions, and restrictions. Exclusion Criteria: * A medical history and/or condition that is considered significant * Clinically significant allergic reactions, hypersensitivity * History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis * Active or latent Tuberculosis * Previous monoclonal antibody or fusion protein treatment, or current use of any biologics * Plans to donate whole blood or blood components during the study * Male subject who is planning to have child or donate sperms within 10 weeks after the study drug administration. Female subject who is currently pregnant or lactating, or planning to be pregnant or to breastfeed within 10 weeks after the administration of the study drug * Reasonable evidence or history of drug/alcohol/smoking abuse * Presence of tattoos, sunburn, or other skin disturbances on the injection site * Vulnerable subject

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As listed by the trial registrant

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

Healthy participants

Contacts and locations

Locations

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, South Korea

  • Inje University Busan Paik Hospital

    Busan, Busanjin-gu, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

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