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Looking for participantsPhase1

A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

Sponsor: Chong Kun Dang Pharmaceutical

NCT ID: NCT07358156

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CKD-706 (drug), US-Dupixent (drug), EU-Dupixent (drug)
How long the study runs
Study runs about 9 months (dates as stated)
About the drug or intervention
CKD-706 — drug: One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL · US-Dupixent — drug: One subcutaneous dose of US-Dupixent in pre-filled syringe, 300 mg/2mL · EU-Dupixent — drug: One subcutaneous dose of EU-Dupixent in pre-filled syringe, 300 mg/2mL
Patient visit burden
Not specified by the sponsor

In plain English

This study compares a new medicine called CKD-706 with Dupixent® (the brand used in the US and the brand used in Europe) in healthy adults aged 18 to 55. Researchers will look at how the drug moves through the body, its effects, how the immune system responds to it, and how safe it is. It is funded by Chong Kun Dang Pharmaceutical.

Who can take part

  • Healthy adults aged 18 to 55 with suitable veins for blood samples
  • Body mass index between 18.5 and 29.9, weighing at least 50 kg but under 95 kg
  • Able and willing to give consent and be available for the whole study
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test; men and women who can have children must use two forms of birth control

Who may not be able to

  • People who have had dupilumab (Dupixent or a biosimilar) before
  • Those with serious ongoing diseases, recent surgery or trauma, or planned hospital stays during the study
  • Current cancer or cancer in the past 5 years, or a suspected cancer
  • Weakened immune system or a serious infection within 4 weeks
  • Abnormal blood tests, heart traces (ECG), or vital signs judged important by the doctor
  • Positive tests for drugs of abuse or alcohol, or a history of alcohol or drug misuse
  • Smoking more than 5 cigarettes a day (or equivalent nicotine, including e-cigarettes)
  • Recent live vaccines or plans to have one during the study
  • Positive tests for HIV, hepatitis B or hepatitis C (with some exceptions)
  • Heavy coffee or caffeine use, or unwilling to avoid caffeine as required
  • Blood donation of more than 500 mL in the last 56 days
  • Use of most medicines, vitamins or herbal remedies from 14 days before admission until the end of the study
  • Severe allergies, or allergy to antibodies or any ingredient of the study medicine
  • People who cannot follow the study rules, have taken part before, are in detention or under guardianship, or are staff of the sponsor companies or study site or their close relatives

What taking part involves

  • • Receiving CKD-706, US-Dupixent®, or EU-Dupixent® — Not stated — ask the trial team about how these are given and in what dose
  • • Blood samples taken (participants need suitable veins for repeated samples)
  • • Tests including pregnancy tests, blood tests, heart traces (ECG), and checks of vital signs

Time commitment: The exact number of visits and total study length are not stated — ask the trial team; participants must stay in the clinical unit for part of the study (an in-house stay), be available for the whole study, and follow restrictions on caffeine, smoking, and medicines.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
519
Started
2026-02-09
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for atopic dermatitis
  • • Phase1 - 519 participants
  • • This is a randomised, double-blind, three-arm, parallel group, single-dose, Phase 1 comparative study of CKD-706, US-Dupixent, and EU-Dupixent in healthy adult participants

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with atopic dermatitis

Where?

  • • London - Parexel EPCU London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a randomised, double-blind, three-arm, parallel group, single-dose, Phase 1 comparative study of CKD-706, US-Dupixent, and EU-Dupixent in healthy adult participants.

More detail

Dosing the CKD-706, US Dupixent, or EU-Dupixent 300 mg at Day 1. Blood samples for Pharmacokinetic analysis will be collected on Day 1 - 85. Blood sample for Pharmacodynimic and immunogenicity analysis will be collected on Day 1 - 85.

Atopic Dermatitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

Biomarkers mentioned

have a negativewith positivehas a positiveantibody or positive

What the study is looking for

  • ✓Participant is capable of giving signed agreement to take part
  • ✓Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for...
  • ✓Body-mass index between 18.5 - 29.9 kg/m2 (inclusive) with body weight ≥ 50 kg and \< 95 kg at screening.
  • ✓Participant agrees to be available for the entire duration of the study
  • ✓All female participants must have a negative serum pregnancy test at the screening visit and on admission to the...

Who cannot take part

  • ✗Participant with history of any clinically important disease or disorder which, may either put the participant at...
  • ✗Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned...
  • ✗Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab).
  • ✗Participation in any interventional clinical trial or receipt of any the the study treatment within 30 days (or \< 5...
  • ✗Participant with current cancer or within the past 5 years and suspected cancer or undefined neoplasms.
See the full criteria
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.

Where Is This Study? (1 UK site)

Parexel EPCU London

London HA1 3UJ, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Camilla Rincon

Sponsor contact

CONTACT

+49 30 306851306 camila.rincon@parexel.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01