A Randomized, Double-blind, Placebo-controlled and Multiple Dose Escalation Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease

Keymed Biosciences Co.Ltd1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年11月8日最近更新: 2025年3月19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: 48
试验地点: 1
主要终点: Adverse event

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 is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.

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: 50 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
•The age of the subjects is between 50 and 85 years old.
•BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.

排除标准

•Cognitive impairment of subjects due to other medical or neurological factors (other than AD)
•History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
•With any mental illness that may interfere with the cognitive assessment of the subjects.
•With history of moderate or severe renal dysfunction.
•With Uncontrolled stable hypertension.
•With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
•History of malignancy within 5 years prior to screening.