NCT06432647已完成1 期
ATH-1105 a Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female 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
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
详细描述
The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kg/m2 inclusive.
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Medical Conditions:
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •Any of the following:
- •QTcF >450 ms in males or >470 ms in females
- •QRS duration >110 ms
- •PR interval >220 ms
- •Findings which would make QTc measurements difficult or QTc data uninterpretable.
- •History of additional risk factors for torsades de pointes
- •Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute.
- •Positive hepatitis panel and/or positive human immunodeficiency virus test
- •Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale [C-SSRS]), or a lifetime suicide attempt.
- •Prior/concomitant therapy:
- •Administration of any vaccine in the 30 days prior to dosing.
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes
- •Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing
- •Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in
- •Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in
研究组 & 干预措施
ATH-1105
Experimental
Part A: ATH-1105 administered once as an oral solution.
Part B: ATH-1105 administered once daily as an oral solution for 10 days.
干预措施: ATH-1105 (Drug)
Placebo
Placebo Comparator
Part A: Placebo administered once as an oral solution
Part B: Placebo administered once daily as an oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Severity of Treatment-Emergent Adverse Events
时间窗: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
次要结局
- Area under the plasma concentration time curve (AUC)(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- Half-life (t1/2)(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- Accumulation Ratio (AUC) of IMP in Plasma(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- Amount of IMP excreted unchanged in the urine (Ae)(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- Maximum observed plasma concentration (Cmax)(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- Time to maximum observed plasma concentration (Tmax)(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
- IMP Concentration in Cerebrospinal Fluid(Will occur at calculated maximum plasma concentration.)
- Accumulation Ratio (AUC) of IMP in Urine(Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10)
研究者
研究点 (1)
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