Atopic DermatitisPhase 1CKD-706NCT07358156
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 study testing CKD-706, US-Dupixent and EU-Dupixent in people with Atopic Dermatitis, run by Chong Kun Dang Pharmaceutical at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CKD-706, US-Dupixent and EU-Dupixent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 519 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Feb 2026to 16 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is capable of giving signed informed consent
- Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture.
- 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 Clinical Unit (Day -1).
- 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
- 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.
Who cannot join
- Participant with history of any clinically important disease or disorder which, may either put the participant at risk during study.
- Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalisation during the study period.
- Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab).
- 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.
- Participant with current malignancy or within the past 5 years and suspected malignancy or undefined neoplasms.
- 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.
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- Participant with diagnosis or history of immunodeficiency or increased susceptibility to severe infections, or a clinically significant infection within 4 weeks of screening.
- Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at screening or admission, as judged by the Investigator.
- Participant with white blood cell count < lower limit of normal at screening or admission.
- Participant with any clinically significant abnormal finding in vital signs as judged by the Investigator.
- Any clinically significant abnormalities on 12-lead ECG at screening or admission (Day -1) to the Clinical Unit, as judged by the Investigator.
- Participant with positive screen results for drugs of abuse or alcohol at screening or on admission to the Clinical Unit.
- 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.
- 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.
- 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.
- Participant with known helminthic infection, or within 6 months prior to screening.
- 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.
- 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.
- 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.
- Participant has donated blood (> 500 mL) or blood products within 56 days prior to admission.
- 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.
- 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.
- Participant is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope, and possible consequences of the clinical study.
- Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions.
- Participant has previously been enrolled in this clinical study.
- Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Involvement of any Chong Kun Dang Pharmaceutical, Parexel or study site employee or their close relatives.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Parexel EPCU Berlin
Berlin, State of Berlin, 10115
Camilla Rincon, +49 30 306551306, camila.rincon@parexel.com
United Kingdom1 site, 1 recruiting
- Recruiting
Parexel EPCU London
London, England, HA1 3UJ
Rajni Vekaria, +44 208 156 3613, rajni.vekaria@parexel.com
About this study
Official title: A Randomised, Double-blind, Three-arm, Parallel Group, Single Dose, Phase 1 Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult 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.
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.
- Conditions
- Atopic Dermatitis
- Being tested
- CKD-706, US-Dupixent, EU-Dupixent
- Keywords
- CKD-706
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-706Drug
One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL
US-DupixentDrug
One subcutaneous dose of US-Dupixent in pre-filled syringe, 300 mg/2mL
EU-DupixentDrug
One subcutaneous dose of EU-Dupixent in pre-filled syringe, 300 mg/2mL
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 173 healthy participants receiving one dose of investigational medical product Receives: Drug: CKD-706 |
| Arm 2 | Active comparator | 173 healthy participants receiving one dose of investigational medical product Receives: Drug: US-Dupixent |
| Arm 3 | Active comparator | 173 healthy participants receiving one dose of investigational medical product Receives: Drug: EU-Dupixent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (Cmax)
Measured: Day 1 - 85.
Area under the concentration-time curve from time zero up to infinity (AUC0-inf)
Measured: Day 1 - 85.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Measured: Day 1 - 85.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start9 Feb 2026 (estimated)
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 519 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358156
- Sponsor's protocol ID
- A160_01AD2502
- Other IDs
- 2025-523115-11-00, 2025
- Acronym
- CKD-706
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Three-arm, Parallel Group, Single Dose, Phase 1 Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07358156
- Acronym / sponsor ID
- CKD-706 / A160_01AD2502
- Conditions
- Atopic Dermatitis
- Keywords
- CKD-706
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 519 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 16 Nov 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: CKD-706173 healthy participants receiving one dose of investigational medical product |
| Arm 2 | Active comparator | Drug: US-Dupixent173 healthy participants receiving one dose of investigational medical product |
| Arm 3 | Active comparator | Drug: EU-Dupixent173 healthy participants receiving one dose of investigational medical product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant is capable of giving signed informed consent
- Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture.
- 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 Clinical Unit (Day -1).
Key exclusion criteria (27 listed)
- Participant with history of any clinically important disease or disorder which, may either put the participant at risk during study.
- Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalisation during the study period.
- Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab).
- 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.
- Participant with current malignancy or within the past 5 years and suspected malignancy or undefined neoplasms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-706One subcutaneous dose of CKD-706 in pre-filled syringe, 300 mg/2mL | Drug | Arm 1 |
| US-DupixentOne subcutaneous dose of US-Dupixent in pre-filled syringe, 300 mg/2mL | Drug | Arm 2 |
| EU-DupixentOne subcutaneous dose of EU-Dupixent in pre-filled syringe, 300 mg/2mL | Drug | Arm 3 |
Primary outcome
Maximum serum concentration (Cmax)
Time frame: Day 1 - 85.
Area under the concentration-time curve from time zero up to infinity (AUC0-inf)
Time frame: Day 1 - 85.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Time frame: Day 1 - 85.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-706, US-Dupixent and EU-Dupixent in people with Atopic Dermatitis, run by Chong Kun Dang Pharmaceutical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Rincon (+49 30 306851306, camila.rincon@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum serum concentration (Cmax) (time frame: Day 1 - 85.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.