KCT0005182
尚未招募
未知
A First-in-Human, Phase 1, Randomized, Multi center, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy of AVI-3307 Cream in Healthy Adult Subjects and Atopic Dermatitis Patients
Avixgen0 个研究点目标入组 24 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Diseases of the skin and subcutaneous tissue
- 发起方
- Avixgen
- 入组人数
- 24
- 状态
- 尚未招募
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Part A (Healthy adults)
- •1\) Healthy adults
- •2\) Those aged 19 to 65 at the time of signing an Informed Consent Form (ICF)
- •3\) Those who agree to participate in the clinical trial and voluntarily sign a written Informed Consent Form (ICF)
- •4\) Subjects who are informed about the clinical trial, cooperative, and able to participate in the trial until its end date
- •5\) Those who are deemed to have no clinically significant findings in physical examination, vital signs, laboratory testing, and electrocardiography during screening
- •6\) Those to whom the Investigational Product (IP) can be administered
- •Part B (Atopic Dermatitis patients)
- •1\) The following atopic dermatitis patients:
- •\- Patients diagnosed to have atopic dermatitis based on the Hanifin and Rajka diagnostic criteria (i.e.,, patients who have at least three (3\) of the four (4\) major features accompanied by three or more minor features provided in the Hanifin and Rajka diagnostic criteria\*)
排除标准
- •Part A (Healthy adults)
- •1\) Those who have any of the following skin diseases:
- •\- Those with any visually confirmed skin diseases
- •\- Those with psoriasis or active atopic dermatitis, or eczema
- •\- Those with a medical history of atopic dermatitis
- •2\) Those with any uncontrollable chronic diseases (e.g., chronic active hepatitis, hypertension, diabetes or the like)
- •3\) Those with a medical history of other clinically significant or past diseases in the liver, kidney, digestive system, respiratory system, nervous system, cardiovascular system, and blood/tumor
- •4\) Those with sitting systolic blood pressure of \=150 mmHg or \=90 mmHg and diastolic blood pressure of \=100 mmHg or \=55 mmHg during screening
- •5\) Those with a medical history including clinically significant or serious allergy that requires acute or chronic care (e.g., seasonal, pet, environment, food allergies or the like)
- •6\) Those who received oral steroids or oral antibiotics, systemic photochemotherapy, and other immunosuppressants within four (4\) weeks prior to a screening visit
结局指标
主要结局
未指定
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