A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Occurrence and severity of adverse events (AEs)
研究概览
简要总结
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.
详细描述
This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each IP will be labeled with a unique IP number, and the number will be associated with the randomized treatment group. Interactive Web Response System (IWRS) will be used to assign a randomization number and IP number.
As YH35324, placebo, and omalizumab differ in appearance, the assigned treatment group of subjects should be disclosed to study pharmacists and unblinded staff who prepare (taking an appropriate and correct amount (mL) of the IP based on the subject's body weight into a syringe), dispense, and administer the IPs, in order to maintain the blind. Therefore, the treatment group information of subjects will be checked through IWRS with limited access before administration of the IP, and only study pharmacists and unblinded staff are allowed to access the system.
The study pharmacists and unblinded staff should not disclose the assigned treatment group of enrolled subjects to the principal investigator or study staff.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults aged ≥ 19 to ≤ 75 years
- •[Parts 1 and 2 only]
- •Diagnosis of CSU at least 6 months prior to screening
- •Diagnosis of CSU inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
- •[Part 2 only]
- •Experience of inadequately uncontrolled CSU despite use of omalizumab
- •[Part 3 only]
- •Diagnosis of chronic inducible urticaria (cold urticaria) at least 3 months prior to screening
- •Diagnosis of chronic inducible urticaria (cold urticaria) inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
排除标准
- •History of malignancy within 5 years from screening
- •Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal
- •[Parts 1 and 2 only]
- •Chronic urticaria with clear etiology other than CSU
- •[Part 3 only]
- •Chronic urticaria other than studied chronic inducible urticaria (cold urticaria)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
YH35324
[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group.
[Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.
[Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.
干预措施: YH35324 (Drug)
Omalizumab
[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group.
干预措施: Omalizumab (Drug)
Placebo
[Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.
[Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence and severity of adverse events (AEs)
时间窗: Occurrence and severity of adverse events will be observed for 57 days after administration
To evaluate the safety and tolerability following single administration of YH35324
次要结局
- Change in serum free IgE level(Change in serum free IgE will be observed for 57 days after administration)