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Completed

NCT Number: NCT06391593

PD, PK, and Safety of ALTO-203 in Patients With MDD

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.

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Key information

Conditions

Major Depressive Disorder Anhedonia Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 4058, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ALTO-203 25 μg

Drug

Active, ALTO-203 25 μg

ALTO-203 75 μg

Drug

Active, ALTO-203 75 μg

Placebo

Drug

Comparator, Placebo-to-match

Primary outcomes

  1. 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).

    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

    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.

  2. 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.

    Time frame: Multi-Dose Treatment Period Day 1 to Day 35

    Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.

Secondary outcomes

  1. 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.

    Time frame: Single-Dose Treatment Period Day 1 to Day 21

    Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.

  2. Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation

    Time frame: Multi-Dose Treatment Period Day 1 to Day 35

    Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing.

Sponsors and collaborators

Lead sponsor

Alto Neuroscience

Industry

Registry information

Official study title

Double-Blind, Single and Multiple Dose Study to Determine Pharmacodynamic Markers, Pharmacokinetic Parameters, and Safety of ALTO-203 in Patients With Major Depressive Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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