NCT06713317已完成1 期
A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Incidence rate of drug allergy following intradermal injection of the IP
研究概览
简要总结
Part I) multi-center, randomized, double-blind, placebo controlled
Part II) multi-center, randomized, double-blind, placebo controlled
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 19 years or older at the time of screening (Visit 1).
- •Subjects with intact skin at the site of administration, without tattoos, acne, dermatitis, pigmentation, or lesions that could interfere with the administration of the investigational drug and allergy testing.
- •[Part II]
- •Subjects who tested negative on the drug allergy assessment after Part 1 intradermal administration.
- •For women of childbearing potential, a negative pregnancy test (serum-hCG) at baseline visit (V5).
排除标准
- •Subjects with the following comorbidities or conditions:
- •Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 2).
- •Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 2).
- •Immune disorders that may affect the immune system (e.g., flu, cancer, HIV).
- •Chronic urticaria, dermographism.
- •Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
- •Clinically significant blood pressure abnormalities.
- •Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
- •Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.
- •Subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (Visit 1).
- •Subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (Visit 2).
- •Other subjects deemed inappropriate for participation in this clinical trial by the investigator.
- •[Part II]
- •Subjects with the following comorbidities or conditions:
- •Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 5).
- •Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 5).
- •Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
- •Clinically significant blood pressure abnormalities.
- •Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
- •Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.
研究组 & 干预措施
Part I 'HLB3-002'
Experimental
Recombinant Hyaluronidase
干预措施: HLB3-002 (Drug)
Part I '0.9%NaCl'
Experimental
0.9% Normal Saline
干预措施: 0.9% NaCl (Drug)
Part II 'HLB3-002'
Experimental
Recombinant Hyaluronidase
干预措施: HLB3-002 (Drug)
Part II '0.9%NaCl'
Experimental
0.9% Normal Saline
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
Incidence rate of drug allergy following intradermal injection of the IP
时间窗: 2 days
Subject developing allergic reaction are considered to have drug allergy.
次要结局
- Incidence rate of drug allergy following subcutaneous injection of the IP(4 weeks)
研究者
研究点 (1)
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