A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
- Conditions
- Atopic Healthy SubjectsAdult Subjects with Mild Allergic Diseases
- Interventions
- Registration Number
- NCT05061524
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YH35324 YH35324 * Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed Placebo Placebo * Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: Placebo is not administered in Part B Xolair® for injection (Omalizumab) Omalizumab * Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) * Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability following single administration of YH35324 Occurrence and severity of adverse events will be observed for 113 days after administration Occurrence and severity of adverse events (AEs)
- Secondary Outcome Measures
Name Time Method To evaluate the PK of YH35324 Serum concentrations of YH35324 will be observed for 113 days after administration Serum concentrations of YH35324
To evaluate the PD of YH35324 Change in serum Free/Total IgE level will be observed for 113 days after administration Change in serum Free/Total IgE level
Trial Locations
- Locations (4)
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Sinchon-dong, Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gumi, Sungnamsi, Korea, Republic of
Asan Medical Center
🇰🇷Pungnap-tong, Seoul, Korea, Republic of