NCT06553209已完成1 期
A Randomized, Double-blind, Single/Multiple Dose Escalation, Placebo-controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM512 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年9月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- •Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).
排除标准
- •Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.
- •Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.
- •Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.
- •Positive drug abuse test or positive alcohol breath test result.
研究组 & 干预措施
Group 1
Experimental
干预措施: CM512 (Biological)
Group 7
Experimental
干预措施: CM512 (Biological)
Group 7
Experimental
干预措施: Placebo (Drug)
Group 1
Experimental
干预措施: Placebo (Drug)
Group 2
Experimental
干预措施: CM512 (Biological)
Group 2
Experimental
干预措施: Placebo (Drug)
Group 3
Experimental
干预措施: CM512 (Biological)
Group 3
Experimental
干预措施: Placebo (Drug)
Group 4
Experimental
干预措施: CM512 (Biological)
Group 4
Experimental
干预措施: Placebo (Drug)
Group 5
Experimental
干预措施: CM512 (Biological)
Group 5
Experimental
干预措施: Placebo (Drug)
Group 6
Experimental
干预措施: CM512 (Biological)
Group 6
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: Up to 141 days or up to 169 days
Incidence of adverse events.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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