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

NCT07358156 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: A160_01AD25022025-523115-11-00
• Study Type: interventional
• Target: 519
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Atopic Dermatitis

Keywords

CKD-706

Outcome Measures

Primary Outcomes (3)

• Maximum serum concentration (Cmax)

  Day 1 - 85.

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

  Day 1 - 85.

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

  Day 1 - 85.

Study Arms (3)

Arm 1

EXPERIMENTAL

173 healthy participants receiving one dose of investigational medical product

Drug: CKD-706

Arm 2

ACTIVE COMPARATOR

173 healthy participants receiving one dose of investigational medical product

Drug: US-Dupixent

Arm 3

ACTIVE COMPARATOR

173 healthy participants receiving one dose of investigational medical product

Drug: EU-Dupixent

Interventions

CKD-706 DRUG

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

Arm 1

US-Dupixent DRUG

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

Arm 2

EU-Dupixent DRUG

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

Arm 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Parexel: collaborator

Study Sites (2)

Parexel EPCU Berlin

Berlin, State of Berlin, 10115, Germany

NOT YET RECRUITING

Parexel EPCU London

London, England, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Camilla Rincon

CONTACT

+49 30 306851306; camila.rincon@parexel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): November 16, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

GB (1); DE (1)