A Randomized, Double Blind, Placebo-controlled, Multiple-dose, Parallel Phase Ⅰ Study to Evaluate Safety and Compare the Immune Stimulating Efficacy of "DF19001" in Dermatophagoides Farinae Sensitized Allergic Rhinitis Volunteers
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.
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)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
- •ImmunoCAP® titer > 3.49 kUA/L for the house dust mite antigen.
- •Determined to be suitable for clinical trials as a result of laboratory tests.
排除标准
- •Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
- •In case of lactation or pregnancy.
- •If an infectious disease that may affect this study is identified.
- •Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
- •If the allergy skin prick test is negative for the house dust mite antigen.
研究组 & 干预措施
1Arm A
As the maintenance UNIT, 200 PAU
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
1Arm B
Placebo arm of 1Arm A.
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
2Arm C
As the maintenance UNIT, 400 PAU
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
2Arm D
Placebo arm of 2Arm C.
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
3Arm E
As the maintenance UNIT, 800 PAU
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
3Arm F
Placebo arm of 3Arm E.
干预措施: House Dust Mite Extract, Dermatophagoides Farinae (Drug)
结局指标
主要结局
Vital signs
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
laboratory test
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood chemistry test
Local Adverse Event
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Local adverse events are removed from the subject 4 hours after attaching the clinical trial drug, and the attachment site is photographed and uploaded to the subject's diary (e-diary). The tester evaluates the presence of an adverse reaction through visual evaluation of the photo of the attachment site.
systemic adverse event
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system.
Health examination
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects
Electrocardiography
时间窗: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position.
次要结局
未报告次要终点