A multiple ascending dose, phase 1b Study of YH35324 in atopic healthy subjects

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Yuhan Corporation is conducting the clinical trial of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases.

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with mild allergic diseases, who have atopy. It is planned to include 34 participants.

It is planned to start enrollment on October 21, 2022. The researchers expect to complete the study by December 31, 2023.

One primary outcome measure is Occurrence and severity of adverse events (AEs), To evaluate the safety and tolerability following multiple administrations of YH35324.

Participants must be male or female adults aged ≥ 19 to ≤ 55 years with serum total IgE level ≥ 30 IU/mL and without any pathological symptoms or findings from medical examination, or subjects with a history of mild allergic diseases (allergic rhinitis, atopic dermatitis, food allergy, urticaria, or allergic asthma).

Whereas subjects with history of malignancy, those with positive drug screen result, having aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal, or with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, or with allergy immunotherapy initiated or changed within 6 months prior to randomization, or with history of participation in another clinical trial within 6 months prior to randomization - will not be included into this study.

The location of the study and further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05564221.

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