A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Male or female adults aged ≥ 19 to ≤ 55 years

• Serum total IgE level ≥ 30 IU/mL

• Healthy subjects 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)

Exclusion Criteria:

• History of malignancy

• Positive drug screen result

• Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal

• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

• Allergy immunotherapy initiated or changed within 6 months prior to randomization

• History of participation in another clinical trial within 6 months prior to randomization