A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
Launched by YUHAN CORPORATION · Sep 27, 2021
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens Based on its non-clinical study results, this study aims to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic diseases.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 19\~55 years old, Atopic Healthy Subjects or Subjects With Mild Allergic Diseases
- • Serum total IgE level of 30 to 700 IU/mL or \> 700 IU/mL
- • Signed the informed consent form
- Exclusion Criteria:
- • Hyperimmunoglobulin E syndrome or malignancy
- • Positive drug screen result
- • AST or ALT \> 1.5 \* Upper normal range
- • eGFR \< 60mL/min/1.73m2
- • Allergy immunotherapy initiated or Administration of a live vaccine within 3 months prior to randomization
- • History of participation in another clinical trial within 6 months prior to randomization
About Yuhan Corporation
Yuhan Corporation is a leading South Korean pharmaceutical company dedicated to the research, development, manufacturing, and marketing of innovative healthcare solutions. Established in 1926, Yuhan has a robust portfolio that includes prescription medications, over-the-counter products, and biologics, with a strong emphasis on oncology, infectious diseases, and central nervous system disorders. The company is committed to advancing medical science through strategic partnerships, cutting-edge research, and clinical trials aimed at bringing novel therapies to market. Yuhan's dedication to quality and excellence positions it as a prominent player in the global pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Suwon Si, Gyeonggi Do, Korea, Republic Of
Pungnap Tong, Seoul, Korea, Republic Of
Sinchon Dong, Seoul, Korea, Republic Of
Gumi, Sungnamsi, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials