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.
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
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.
Chong Kun Dang Pharmaceutical
Lead sponsor
Parexel
Collaborator