A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of SHR-1707 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Adverse events(AEs)
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- •Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
- •Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive)at screening or baseline.
- •The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
- •The subjects should have a stable caregiver who will help the patients to participate in the whole study process.
排除标准
- •Cognitive impairment due to other medical or neurological factors (non-AD).
- •History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
- •Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
- •Inability to tolerate MRI examination or have contraindications to MRI examination.
- •Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
- •Exclusion criteria related to general or laboratory tests, as listed in the protocol.
- •The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
- •Severe visual or hearing impairment, unable to cooperate in the scale examination.
- •Patients suspected to be allergic to Aβ antibody drugs and their excipients.
- •Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.
- •History of drug abuse and/or drug addiction within 1 year prior to screening.
- •13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.
- •14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.
- •Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.
- •Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
- •Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
研究组 & 干预措施
Dose level 1 SHR-1707
SHR-1707 is administered intravenously.
干预措施: SHR-1707 injection (Drug)
Dose level 1 Placebo
Placebo is administered intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events(AEs)
时间窗: week 26
To assess the number of patients with adverse events
Baseline in vital signs value
时间窗: week 26
To assess the number of patients with clinically significant change from baseline in vital signs value
Physical examination
时间窗: week 26
To assess the number of patients with clinically significant change in physical examination
Laboratory examination
时间窗: week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Baseline in 12-ECG values
时间窗: week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
MRI
时间窗: week 26
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
次要结局
- Aβ positron emission tomography (PET)(week 26)
- Concentrations of SHR-1707(week 26)
- Anti-Drug antibody(week 26)