NCT04973189已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
- •Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
- •Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~28 kg/m2 (inclusive)
- •Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
- •WOCBP agree to take effective contraceptive methods
排除标准
- •Severe injuries or surgeries within 6 months before screening
- •Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at screening
- •ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
- •QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
- •Known history or suspected of being allergic to Aβ antibody
- •Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives
- •Live (attenuated) vaccination within 1 month before screening
- •Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
- •History of alcohol abuse in the past 12 months of screening
- •History of illicit or prescription drug abuse or addiction within 12 months of screening
- •More than 5 cigarettes daily for 12 months before screening
- •Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
- •Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program
- •The instigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
placebo in elderly subject
Placebo Comparator
干预措施: Placebo (Drug)
A single dose of SHR-1707 by intravenous infusion in healthy young adults.
Experimental
干预措施: SHR-1707 (Drug)
placebo in healthy young adults.
Placebo Comparator
干预措施: Placebo (Drug)
A single dose of SHR-1707 by intravenous infusion in elderly subjects.
Experimental
干预措施: SHR-1707 (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
时间窗: Start of Treatment to end of study (approximately 12 weeks)
Incidence and severity of adverse events
次要结局
- Clearance (CL) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
- Mean residence time (MRT) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
- Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
- Time to Cmax (Tmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
- Number of subjects with Anti-SHR-1707 antibodies(Start of Treatment to end of study (approximately 12 weeks))
- Maximum observed concentration (Cmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
- Terminal elimination half-life (t1/2) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
- The change from baseline in plasma Aβ40 and Aβ42 concentrations(Start of Treatment to end of study (approximately 12 weeks))
- Volume of distribution (Vss) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
研究者
研究点 (1)
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