Actively Recruiting
A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
Led by Chong Kun Dang Pharmaceutical · Updated on 2026-01-23
519
Participants Needed
2
Research Sites
40 weeks
Total Duration
On this page
Sponsors
C
Chong Kun Dang Pharmaceutical
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Healthy males and females aged 18 to 55 years with suitable veins for blood sampling
- Body mass index between 18.5 and 29.9 kg/m2 and body weight between 50 kg and less than 95 kg
- Agree to be available for the entire study duration
- Female participants must have negative pregnancy tests at screening and admission
- Female participants must not be pregnant, lactating, or breastfeeding and meet specific conditions
- Male participants and female partners must use two forms of birth control from screening until 3 months after dosing
You will not qualify if you...
- History of any significant medical disease or disorder that could risk participant safety
- Recent major surgery, trauma, or planned hospitalization during study
- Prior exposure to dupilumab or biosimilars
- Participation in other clinical trials or use of investigational products within 30 days prior to dosing
- Current or recent malignancy or suspected cancer
- Chronic or acute gastrointestinal, liver, kidney, or pancreatic disease
- History or presence of immune deficiency or recent serious infection
- Abnormal clinical lab results or vital signs judged significant by investigator
- Abnormal 12-lead ECG results
- Positive drug or alcohol screening or history of substance abuse
- Smoking more than 5 cigarettes per day or inability to refrain during in-house stay
- Recent live vaccine administration or planned during study
- Known helminth infection
- Positive tests for HIV, Hepatitis B or C unless resolved
- Excessive caffeine use or unwillingness to avoid caffeine before admission
- Recent blood donation over 500 mL
- Use of medications or supplements from 14 days prior to admission through study end
- History of severe allergies or hypersensitivity to monoclonal antibodies or study drug components
- Inability to understand or comply with study requirements
- Previous enrollment in this study
- Vulnerable participants such as those under guardianship or institutionalized
- Employees or close relatives of the sponsor or study site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Parexel EPCU Berlin
Berlin, State of Berlin, Germany, 10115
Not Yet Recruiting
2
Parexel EPCU London
London, England, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
C
Camilla Rincon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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