A First-in-Human, Randomized, Double-Blind, Placebo/Active Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability following single administration of YH35324
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: YH35324 (Drug)
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
干预措施: Placebo (Drug)
Xolair® for injection (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.
干预措施: Omalizumab (Drug)
结局指标
主要结局
To evaluate the safety and tolerability following single administration of YH35324
时间窗: Occurrence and severity of adverse events will be observed for 113 days after administration
Occurrence and severity of adverse events (AEs)
次要结局
- To evaluate the PD of YH35324(Change in serum Free/Total IgE level will be observed for 113 days after administration)
- To evaluate the PK of YH35324(Serum concentrations of YH35324 will be observed for 113 days after administration)