ClinicalTrials.gg
RecruitingNCT07358156CKD-706Updated Jan 23, 2026

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

A Phase 1 interventional study of CKD-706 and US-Dupixent in Atopic Dermatitis, sponsored by Chong Kun Dang Pharmaceutical. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
519
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 229 studies in Dermatitis, Atopic with a site in Germany — 18 open to participants now, 41 under way, 9 of them phase 3. Dermatitis, Atopic · Germany.

Planned enrollment
40th of 205
519 · median 195
Started
2026
with 4 others
Phase 1
21 of 229
2 open now
Primary completion
2026-11
later than 9 of 40 live
Registered
225th of 229
by date

Among the 229 studies in Dermatitis, Atopic with a site in Germany, this one is the 40th largest by planned enrollment of the 205 interventional ones that give a count, is one of 5 that started in 2026, is one of 21 in phase 1, reaches primary completion later than 9 of the 40 other live ones, and was the 225th registered.

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 519 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Open to participants now

18 of the 229 studies in Dermatitis, Atopic with a site in Germany are open now.

All 18 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 229 studies in Dermatitis, Atopic with a site in Germany, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Atopic Dermatitis

Browse trials for

Keywords

  • CKD-706
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant is capable of giving signed
  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 must be using 2 forms of from screening until at least 3 months after the end of study intervention dose.

Exclusion criteria

Exclusion Criteria:

  1. Participant with history of any 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 product within 30 days (or \< 5 half-lives of investigational drug taken) prior to dosing.
  5. Participant with current 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 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 (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 antibody or positive results for surface antigen, anti-hepatitis B core antibody or 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/ 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
519 participants (estimated)

Study arms

  • Experimental
    Arm 1

    173 healthy participants receiving one dose of investigational medical product

    Drug: CKD-706

  • Active comparator
    Arm 2

    173 healthy participants receiving one dose of investigational medical product

    Drug: US-Dupixent

  • Active comparator
    Arm 3

    173 healthy participants receiving one dose of investigational medical product

    Drug: EU-Dupixent

Interventions

  • DrugCKD-706

    One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL

  • DrugUS-Dupixent

    One subcutaneous dose of US-Dupixent in pre-filled syringe, 300 mg/2mL

  • DrugEU-Dupixent

    One subcutaneous dose of EU-Dupixent in pre-filled syringe, 300 mg/2mL

This study also gives Dupilumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Maximum serum concentration (Cmax)

    Time frame: Day 1 - 85.

  2. Area under the concentration-time curve from time zero up to infinity (AUC0-inf)

    Time frame: Day 1 - 85.

  3. Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)

    Time frame: Day 1 - 85.

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Nov 2026, 9 months later.

Of 114 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 9 months is below that.

Counting every sponsor, half of 131 studies reached it within 13 months; a quarter within 5 and three quarters within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Jan 22, 2026
StartEst.
Feb 9, 2026
Primary completionEst.
Nov 16, 2026
CompletionEst.
Nov 16, 2026
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07358156
Collaborators
Parexel
Responsible party
Sponsor
First posted
Jan 22, 2026
Start date
Feb 9, 2026 (estimated)
Primary completion
Nov 16, 2026 (estimated)
Completion
Nov 16, 2026 (estimated)
Last update
Jan 23, 2026

Study contacts

Camilla Rincon
Contact
camila.rincon@parexel.com
+49 30 306851306

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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