A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects

Keymed Biosciences Co.Ltd1 个研究点分布在 1 个国家目标入组 56 人开始时间: 2024年5月28日最近更新: 2024年11月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 56
试验地点: 1
主要终点: Adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

详细描述

Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
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 80 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy males, voluntarily participate;
•18 and 80 years old (including boundary values);
•able to communicate well with the researchers and follow up the protocol requirements.

排除标准

•The average daily smoking volume within three months before screening is greater than 5 cigarettes;
•Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
•Urine drug abuse screening is positive;
•Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.