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

Phase 2

Recruiting

• Conditions: Anhedonia; Major Depressive Disorder
• Interventions: Drug: ALTO-203 25 μg; Drug: ALTO-203 75 μg; Drug: Placebo

• Registration Number: NCT06391593
• Lead Sponsor: Alto Neuroscience

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ALTO-203 25 μg	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
ALTO-203 75 μg	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
Placebo	Placebo	Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days

Primary Outcome Measures

Name	Time	Method
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).	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.	Multi-Dose Treatment Period Day 1 to Day 35	Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.

Secondary Outcome Measures

Name	Time	Method
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	Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing.
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	Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.

Trial Locations

Locations (15)

Site 4058; 🇺🇸 Tucson, Arizona, United States

Site 4082; 🇺🇸 Oceanside, California, United States

Site 4059; 🇺🇸 Clermont, Florida, United States

Site 4054; 🇺🇸 Pikesville, Maryland, United States

Site 4023; 🇺🇸 Torrance, California, United States

Site 4031; 🇺🇸 Atlanta, Georgia, United States

Site 4036; 🇺🇸 Las Vegas, Nevada, United States

Site 4022; 🇺🇸 Berlin, New Jersey, United States

Site 4134; 🇺🇸 Princeton, New Jersey, United States

Site 4072; 🇺🇸 Houston, Texas, United States

Site 4005; 🇺🇸 Orlando, Florida, United States

Site 4040; 🇺🇸 Austin, Texas, United States

Site 4007; 🇺🇸 Clinton, Utah, United States

Site 4075; 🇺🇸 Westlake, Ohio, United States

Site 4033; 🇺🇸 Bellevue, Washington, United States