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.
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
• 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.