NCT06009094已完成1 期
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
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
- 80
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax）
研究概览
简要总结
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subject's study:
- •Healthy male or female subjects, aged 18-45 years (including critical values);
- •Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
- •All women and men with fertility potential must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
- •Voluntarily participate in the experiment and sign an informed consent form;
- •Subjects who are able to communicate well with the researcher and are willing and able to comply with all planned visits, treatment plans, laboratory tests, and other research procedures
- •patient's study:
- •When informed consent is given, the age range is between 18 and 75 years (including the boundary value), regardless of gender;
- •Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
- •Before administration, the diagnosis of mild to moderate atopic dermatitis should be met:
- •Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total area of skin lesions 3% ≤ body surface area≤ 20%
- •Voluntarily sign an informed consent form (with a date), indicating that the subject has been informed of all relevant parts of the study;
- •All women and men with the possibility of childbirth must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
- •Subjects who are willing and able to comply with planned visits and treatment plans, laboratory tests, and other research procedures
排除标准
- •healthy subject's study:
- •Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- •Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
- •Screening for individuals who have undergone any surgery within the previous 6 months;
- •Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
- •Female subjects of childbearing age had unprotected sexual intercourse with their opposite sex partner within 14 days prior to screening;
- •Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;
- •Pregnant and lactating women;
- •Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- •Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
- •Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
- •Other situations where the researcher determines that it is not suitable to participate in the experiment.
- •patient's study:
- •Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- •Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
- •Screening for individuals who have undergone any surgery within the previous 6 months;
- •Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
- •Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;
- •Pregnant and lactating women;
- •Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- •Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
- •Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
- •Other situations where the researcher determines that it is not suitable to participate in the experiment.
研究组 & 干预措施
VC005 Low Dose groups
Experimental
干预措施: VC005 (Drug)
VC005 median-A Dose groups
Experimental
干预措施: VC005 (Drug)
VC005 median-B Dose groups
Experimental
干预措施: VC005 (Drug)
VC005 high Dose groups
Experimental
干预措施: VC005 (Drug)
VC005 Placebo groups
Placebo Comparator
干预措施: VC005 Placebo (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax）
时间窗: Day2,Day 4,Day17,Day31
次要结局
- Changes in EASI（Eczema area and severity index） from baseline(Week 2,Week 4)
研究者
研究点 (1)
Loading locations...
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