A Phase I, Open-Label, Comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of CKD-706 in Healthy Adult Participants

The primary objective of this study is to evaluate the pharmacokinetics, pharmacodynamics, immunogenicity, and safety of CKD-706 in comparison to US-Dupixent® and EU-Dupixent® in healthy adult participants. Establishing these parameters is essential for characterizing the drug's absorption, distribution, metabolism, and excretion, as well as its biological effects and potential for inducing an immune response. The study aims to assess the pharmacological profile of CKD-706 relative to established versions of the reference product to support its development for indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease.

This Phase I study involves 184 healthy volunteers. The participant population includes both males and females within the age range corresponding to code 3. The study population includes vulnerable individuals. The intended therapeutic indications for the investigation include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease.

This Phase I study is designed as a comparative investigation to evaluate the pharmacokinetics, pharmacodynamics, immunogenicity, and safety of CKD-706 in relation to US-Dupixent® and EU-Dupixent®. The research methodology involves the assessment of healthy adult participants to determine the profile of the investigational product across several intended indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease. The trial procedures consist of a sequence of study visits, beginning with a screening visit to assess eligibility, followed by scheduled follow-up visits, and concluding with an end-of-study visit. The total duration of participant involvement is determined by the clinical protocol, and the study may be terminated early if specific predefined conditions are met.

The assessment of efficacy in this Phase I clinical trial is not specified. The study involves healthy participants and focuses on various indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease.