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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Active, ALTO-203 25 μg
Active, ALTO-203 75 μg
Comparator, Placebo-to-match
Site 4058
Tucson, Arizona, United States
Site 4082
Oceanside, California, United States
Site 4023
Torrance, California, United States
Site 4059
Clermont, Florida, United States
Site 4005
Orlando, Florida, United States
Site 4031
Atlanta, Georgia, United States
Site 4054
Pikesville, Maryland, United States
Site 4036
Las Vegas, Nevada, United States
Site 4022
Marlton, New Jersey, United States
Site 4134
Princeton, New Jersey, United States
...and 5 more locations
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).
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.
Time frame: Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3
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.
Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.
Time frame: 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.
Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.
Time frame: Single-Dose Treatment Period Day 1 to Day 21
Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation
Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing.
Time frame: Multi-Dose Treatment Period Day 1 to Day 35
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