A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
NCT07358156
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Chong Kun Dang Pharmaceutical
Start date
2026-02-09
Number of sites
- 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.
- Acronym
- CKD-706
- Short title
- A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
- 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.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-11-16
- First posted
- 2026-01-22
- Registry last updated
- 2026-01-23
- Primary completion date
- 2026-11-16
- Start date
- 2026-02-09
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07358156
- ClinicalTrials.gov ID
- NCT07358156
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Sources for study design
Maximum serum concentration (Cmax)
Timeframe: Day 1 - 85.
Area under the concentration-time curve from time zero up to infinity (AUC0-inf)
Timeframe: Day 1 - 85.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Timeframe: Day 1 - 85.
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
-
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.
- 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.
- 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.
Sources for eligibility
- Parexel EPCU BerlinBerlin, GermanyNot yet recruiting
- Parexel EPCU LondonLondon, United KingdomRecruiting
Sources for sites
- 2025
- 2025-523115-11-00
Sources for references
Related records
Drugs (1)
Collaborators (1)
- Parexel
Lead sponsors (1)
Conditions (1)
- Atopic eczema Primary condition