NCT05995782招募中1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult Subjects and Healthy Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
详细描述
Part A:
Primary:
To assess the safety and tolerability of single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
Secondary:
To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses of FB418 in healthy adult subjects and healthy 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
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male 19 55 years of age, inclusive, at the screening.
- •For elderly subjects(Part A Cohort 5 only), healthy, elderly, male or female (of non childbearing potential only) over 60 years of age, inclusive, at screening.
- •In the case of the elderly(Part A Cohort 5 only), they have a history of mild disease, but can participate if the researcher judges that they can stop taking the drug at least 2 weeks before the expected first dose or before the half-life is 5 times or more)
- •The continuous non smoker who have not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study are based on subjective self reporting.
- •Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening.
- •Medically healthy with no clinically significant medical history, physical examination, simplified neurological examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- •In Cohort 5, A female subject must be of non childbearing potential
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •Is at suicidal risk in the opinion of the PI as per the following criteria:
- •Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.
- •C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening.
- •History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- •History of seizures (childhood febrile seizures are excepted).
- •Positive urine drug or alcohol results at screening or check in.
- •Has an abnormal screening ECG indicating a second- or third- degree AV block, or one or more of the following: QRS > 120 msec, QTcF > 450 msec for males and > 460 msec for females, PR interval > 220 msec. Any rhythm other than normal sinus rhythm, which is interpreted by the PI or designee to be clinically significant at screening or check-in.
- •Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.
研究组 & 干预措施
FB418
Experimental
Part A - Single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
Part B - Multiple ascending oral doses FB418 in healthy adult subjects.
干预措施: FB418 (Drug)
FB418-Placebo
Placebo Comparator
Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
干预措施: FB418 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAE)
时间窗: Up to 7 ~ 14 days after the last dose
Number of TEAEs including serious adverse events (SAEs)
次要结局
- PK parameter 1(Up to 72 hours after the last dose)
- PK parameter 4(Up to 72 hours after the last dose)
- PK parameter 2(Up to 72 hours after the last dose)
- PK parameter 5(Up to 72 hours after the last dose)
- PK parameter 3(Up to 72 hours after the last dose)
研究者
研究点 (1)
Loading locations...
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