A Phase 1, Single-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma, Urine and CSF of Single and Multiple Ascending Doses of ALZ-507 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Alzheon Inc.
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507
研究概览
简要总结
Researchers are testing an investigational medicine called ALZ-507 in healthy adults between 50 and 75 years of age.
The purpose of this study is to learn:
Assess if oral ALZ-507 is safe What side effects may occur How the body absorbs ALZ-507 Whether food affects how ALZ-507 is absorbed How much ALZ-507 reaches the blood, cerebrospinal fluid, and urine
Participants will receive either ALZ-507 or a placebo. Some participants will receive a single dose, while others will receive daily doses for two weeks. Researchers will monitor participants closely through medical examinations, laboratory testing, and collection of blood, cerebrospinal fluid and urine.
The findings from this study will help guide the future development of ALZ-507.
The information from this study will help determine whether ALZ-507 is safe for further clinical development.
详细描述
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ALZ-507 following single ascending doses (SAD) and multiple ascending doses (MAD) in healthy adult participants aged 50 to 75 years.
ALZ-507 is an investigational oral formulation. The study will evaluate the safety profile of ALZ-507 and characterize its pharmacokinetic properties in plasma, urine, and cerebrospinal fluid (CSF).
The study consists of two parts:
Part 1: Single Ascending Dose (SAD)
Part 1 will evaluate the safety, tolerability, and plasma and urine pharmacokinetics of single ascending oral doses of ALZ-507 in healthy participants. Up to 60 participants will be enrolled into sequential dose cohorts and randomized in a 3:1 ratio to receive ALZ-507 or matching placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged 50 to 75 years, inclusive
- •Body mass index 18.0 to 35.0 kg/m2, inclusive, and >50 kg body weight
- •No clinically significant values for vital signs (systolic blood pressure [BP] 90 to 140 mmHg, diastolic BP 40 to 90 mmHg, and HR 50 to 100 bpm) and no clinically significant ECG readings, as determined by the principal investigator or sub investigator
排除标准
- •Participation in a clinical research study within the previous 30 days or within a period of less than 5 times the drug's half-life
- •Have previously participated in a trial with ALZ-801 or tramiprosate and received study drug
- •History of any drug or alcohol abuse in the past 2 years
- •Creatinine clearance of <60 mL/min using the Cockcroft-Gault equation at screening
- •Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
- •History of clinically significant cardiovascular, pulmonary, chronic respiratory, renal, hepatic, GI, immunologic, endocrine, neurologic, psychiatric or thromboembolic disease; a history of metabolic disturbances; or any current physical conditions that could interfere with the interpretation of the study results as judged by the investigator
研究组 & 干预措施
Placebo-Controlled
干预措施: Placebo (Drug)
Experimental Arm
干预措施: ALZ-507 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507
时间窗: From first dose through the follow-up visit (up to approximately 31 days in Part 1 and up to approximately 35 days in Part 2).
次要结局
- Amount of ALZ-507 excreted in urine following single ascending doses(Predose through 144 hours after dosing)
- Maximum observed plasma concentration (Cmax) of ALZ-507 following single ascending doses(Predose through 144 hours (7 days) after administration of a single dose of ALZ-507)
- Maximum observed plasma concentration (Cmax) of ALZ-507 under fed and fasted conditions(Predose through 144 hours (7 days) after administration of a single dose of ALZ-507 under fed and fasted conditions)
- Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses(Predose on Day 1 through 144 hours after the final dose on Day 14 (up to Day 20))
- Amount of ALZ-507 excreted in urine at steady state(Day 14 through Day 20)
- Cerebrospinal Fluid Concentration Following Multiple Doses of ALZ-507(Approximately 2 hours after dosing on Day 14)
- Area under the plasma concentration-time curve (AUC) of ALZ-507 following single ascending doses(Predose through 144 hours after dosing)
- Area under the plasma concentration-time curve (AUC) of ALZ-507 under fed and fasted conditions(Predose through 144 hours after dosing)
- Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses(Day 14 through Day 20)