Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New biosimilar aims to offer cheaper eczema treatment

NCT ID NCT07358156

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called CKD-706, which is a biosimilar (a close copy) of the approved eczema treatment Dupixent. The study involves 519 healthy adults who will receive a single injection of either CKD-706, the US version of Dupixent, or the European version. Researchers will compare how the drugs move through the body and check for side effects, but this study does not test whether the drug actually improves eczema symptoms.

What this could mean

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

Active substance
CKD-706 (a biosimilar to Dupixent)
What this could lead to
If successful, this could lead to a more affordable treatment option for atopic dermatitis, similar to Dupixent.
What could go wrong
This is an early Phase 1 study in healthy people, not patients. It only tests a single dose, so it cannot show if the drug actually treats the disease. The biosimilar may not work as well as the original.

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 519 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Nov 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

18 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: 1. Participant is capable of giving signed informed consent 2. Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture. 3. Body-mass index between 18.5 - 29.9 kg/m2 (inclusive) with body weight ≥ 50 kg and \< 95 kg at screening. 4. Participant agrees to be available for the entire duration of the study 5. All female participants must have a negative serum pregnancy test at the screening visit and on admission to the Clinical Unit (Day -1). 6. Female Participants: • A female participant is eligible to participate if she is not pregnant, not be lactating and not breastfeeding, and at least one of the following conditions applies 7. Male Participants • Male participants and their female spouse/partners who are of childbearing potential must be using 2 forms of birth control from screening until at least 3 months after the end of study intervention dose. Exclusion Criteria: 1. Participant with history of any clinically important disease or disorder which, may either put the participant at risk during study. 2. Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalisation during the study period. 3. Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab). 4. Participation in any interventional clinical trial or receipt of any investigational product within 30 days (or \< 5 half-lives of investigational drug taken) prior to dosing. 5. Participant with current malignancy or within the past 5 years and suspected malignancy or undefined neoplasms. 6. Participant with history or presence of chronic gastrointestinal, hepatic, renal, or pancreatic disease or ongoing acute disease in these organs, or any other condition constituting a risk when taking the study intervention. 7. Participant with diagnosis or history of immunodeficiency or increased susceptibility to severe infections, or a clinically significant infection within 4 weeks of screening. 8. Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at screening or admission, as judged by the Investigator. 9. Participant with white blood cell count \< lower limit of normal at screening or admission. 10. Participant with any clinically significant abnormal finding in vital signs as judged by the Investigator. 11. Any clinically significant abnormalities on 12-lead ECG at screening or admission (Day -1) to the Clinical Unit, as judged by the Investigator. 12. Participant with positive screen results for drugs of abuse or alcohol at screening or on admission to the Clinical Unit. 13. Known or suspected history of alcohol or illicit drug abuse or excessive intake of alcohol within 1 year of screening, as judged by the Investigator. 14. Participants who smoke more than 5 cigarettes per day or consume equivalent nicotine substitutes, including e-cigarettes or inability to refrain from smoking during the in-house stay period. 15. Participant has received live vaccine(s) or live attenuated vaccines within 1 month prior to screening or plans to receive such vaccines during the study. 16. Participant with known helminthic infection, or within 6 months prior to screening. 17. Participant has a positive test for human immunodeficiency virus antibody or positive results for Hepatitis B surface antigen, anti-hepatitis B core antibody or Hepatitis C virus antibody, except for vaccinated participants or participants with past but resolved hepatitis, at screening. 18. Participant is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission on Day -1 and not consuming caffeine before any outpatient visits. 19. Participant with excess use of caffeine, which is defined as exceeding 500 mg caffeine/day (e.g., \> 5 cups of coffee) within 14 days prior to administration of the study intervention. 20. Participant has donated blood (\> 500 mL) or blood products within 56 days prior to admission. 21. Participant has used over-the-counter medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission until the End of Study visit. 22. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to monoclonal or polyclonal antibodies. History of allergy or reaction to any formulation components of the study intervention. 23. Participant is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope, and possible consequences of the clinical study. 24. Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions. 25. Participant has previously been enrolled in this clinical study. 26. Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. 27. Involvement of any Chong Kun Dang Pharmaceutical, Parexel or study site employee or their close relatives.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atopic dermatitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Parexel EPCU Berlin

    NOT_YET_RECRUITING

    Berlin, State of Berlin, 10115, Germany

  • Parexel EPCU London

    RECRUITING

    London, England, HA1 3UJ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.