Double-Blind, Single and Multiple Dose Study to Determine Pharmacodynamic Markers, Pharmacokinetic Parameters, and Safety of ALTO-203 in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 30
- 主要终点
- Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS).
研究概览
简要总结
The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days.
Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of moderate major depressive disorder (MDD)
- •Presence of anhedonia symptoms
- •Not taking antidepressant at Screening Visit 2
- •Willing to comply with all study assessments and procedures
排除标准
- •Evidence of unstable medical condition
- •Diagnosed bipolar disorder, psychotic disorder, or dementia
- •Concurrent use of prohibited medications
- •Current moderate or severe substance use disorder
- •Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
研究组 & 干预措施
ALTO-203 25 μg
Drug: ALTO-203 25 μg
Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg
Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days
干预措施: ALTO-203 25 μg (Drug)
ALTO-203 75 μg
Drug: ALTO-203 75 μg
Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg
Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days
干预措施: ALTO-203 75 μg (Drug)
Placebo
Drug: Placebo
Single-Dose Treatment Period: Single Dose, Placebo
Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS).
时间窗: Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3
The Bond-Lader Visual Analogue Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 VAS measurements of different mood state. For each question, the participants will rate their feelings at the time of assessment by indicating the point on the 10 cm line which best represents their mood. Each item is scored by measuring the position relative to the left-hand end of the line. The combined domains of alertness and mood will be assessed for the primary endpoint.
Multi-Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the multi-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.
时间窗: Multi-Dose Treatment Period Day 1 to Day 35
Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.
次要结局
- Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation(Multi-Dose Treatment Period Day 1 to Day 35)
- Single Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the single-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.(Single-Dose Treatment Period Day 1 to Day 21)