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

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChong Kun Dang Pharmaceutical

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CKD-706

    Drug

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

  • US-Dupixent

    Drug

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

  • EU-Dupixent

    Drug

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

Treatment groups

519 Participants
are divided into 3 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention
Group C: Arm 3Active comparator 1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chong Kun Dang Pharmaceutical

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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