NCT06786676招募中1 期
A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-oral Administration, Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Korean or Caucasian Adults and Korean Elderly People
Amyloid Solution Inc2 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2025年5月26日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled, single- and multiple-oral administration, phase 1 clinical trial to investigate the safety, tolerability, and pharmacokinetics of AS-S603 in healthy Korean or Caucasian adults and Korean elderly people.
AS-S603 is an orally administered agent developed by Amyloid Solution Inc to treat Alzheimer's disease (AD). It is a small molecule compound that targets and dissolves amyloid-beta (Aβ) and tau aggregates, two key pathologies present in the extracellular and intracellular spaces of brain cells in AD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean adult volunteers aged 19 to 50 years at the time of screening (single dose study)
- •Healthy Korean or Caucasian adult volunteers aged 19 to 50 years at the time of screening (multiple dose study dose groups 1-4)
- •Healthy elderly Korean volunteers aged 65 to 85 years at the time of screening (multiple dose study dose group 5)
- •Individuals with a body weight of ≥ 50.0 kg and ≤ 90.0 kg and a body mass index of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- •Individuals who have given written consent on a voluntary decision to participate and agree to adhere to the precautions after being fully informed of and completely understanding this clinical trial
排除标准
- •Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder.
- •Individuals with a history of a gastrointestinal disorder or surgery that may affect the safety, pharmacokinetic and pharmacodynamic evaluation of the investigational product
- •Individuals who answered 'yes' to any question on the Columbia Suicide Severity Rating Scale administered at the time of screening
- •Individuals with hypersensitivity or a history of clinically significant hypersensitivity to AS-S603 and the same class or other drugs (aspirin, antibiotics, etc.)
- •Individuals with a positive result in the serology test (hepatitis B, hepatitis C, human immunodeficiency virus test, syphilis test)
- •Individuals with a history of drug abuse or a positive urine screening for any drug of concern for abuse
- •Individuals who exhibited the following results on vital signs measured at a sitting position after resting, during the screening tests: Systolic blood pressure < 80 mmHg or ≥ 140 mmHg, Diastolic blood pressure < 45 mmHg or ≥ 90 mmHg
- •Individuals who exhibited QTcB interval > 450 msec (male), 470 msec (female), or clinically significant abnormal findings in rhythm on an electrocardiogram during the screening tests
- •Individuals who exhibited any of the following results on the clinical laboratory test during the screening tests, including additional tests: Aspartate transaminase or alanine transaminase > 60 IU/L, Estimated glomerular filtration rate < 90 mL/min/1.73m2
- •Individuals who had taken any prescription drug or herbal medicine within 2 weeks, or any Over-The-Counter (OTC) drugs, dietary supplements including liver supplements, or vitamin supplements within 1 week prior to the scheduled first administration of investigational product, or are expected to take them
- •Individuals who had taken an inducer or inhibitor of any drug metabolic enzyme, such as barbiturates or clarithromycin, within 1 month prior to the scheduled first administration of investigational product
- •Individuals who have participated and administered investigational product in another clinical trial within 6 months prior to the scheduled first administration of investigational product
- •Individuals who donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the scheduled first administration of investigational product
- •Current smokers
- •Individuals who engage in persistent alcohol consumption or are not able to avoid alcohol consumption from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- •Individuals who have consumed excessive caffeine or are not able to avoid consuming caffeine-containing foods from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- •Individuals who have consumed grapefruit, grapefruit juice, or grapefruit-containing foods or cannot avoid consuming grapefruit-containing foods from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- •Individuals with unusual dietary habits or who cannot adhere to the standardized diet provided by the institution during the confinement period.
- •Women of childbearing potential, individuals whose menstrual period was not confirmed at screening, with a positive urine pregnancy test, or who do not agree to a highly effective contraceptive method for at least 30 days after the last investigational product administration.
- •Men who do not agree to use condoms and ensure that their female partners use a highly effective contraceptive method throughout the entire clinical trial period and for at least 90 days after the last administration of investigational product.
- •Individuals who do not agree to refrain from donating sperm or egg throughout the entire clinical trial period and for at least 90 days after the last administration of investigational product.
- •Individuals who cannot undergo cerebrospinal fluid (CSF) tapping (for groups requiring CSF tapping)
- •Individuals determined to be ineligible for participation in the clinical trial by the investigators due to other reasons
研究组 & 干预措施
Placebo group (Placebo of AS-S603)
Placebo Comparator
Korean and Caucasian Participants
干预措施: Placebo (Drug)
Test group (AS-S603)
Experimental
Korean and Caucasian Participants
干预措施: AS-S603 (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: Up to Day 27
Maximum observed concentration (Cmax)
时间窗: Up to Day 18
Time of maximum observed concentration (Tmax)
时间窗: Up to Day 18
Terminal half-life (t1/2)
时间窗: Up to Day 18
Area under the concentration-time curve from the time of dosing to the time of the last measurable concentration (AUClast)
时间窗: Up to Day 18
Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
时间窗: Up to Day 18
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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