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

Major Depressive Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391593
• Other study ID #: ALTO-203-201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Alto Neuroscience
• Contact: Alto Neuroscience
• Phone: 650-200-0412
• Email: clinical[@]altoneuroscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ALTO-203 25 µg
Active, ALTO-203 25 µg
• ALTO-203 75 µg
Active, ALTO-203 75 µg
• Placebo
Comparator, Placebo-to-match

Locations

Country	Name	City	State
United States	Site 4031	Atlanta	Georgia
United States	Site 4040	Austin	Texas
United States	Site 4033	Bellevue	Washington
United States	Site 4022	Berlin	New Jersey
United States	Site 4059	Clermont	Florida
United States	Site 4007	Clinton	Utah
United States	Site 4072	Houston	Texas
United States	Site 4082	Oceanside	California
United States	Site 4005	Orlando	Florida
United States	Site 4023	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Alto Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3
Primary	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.	Multi-Dose Treatment Period Day 1 to Day 35
Secondary	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.	Single-Dose Treatment Period Day 1 to Day 21
Secondary	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.	Multi-Dose Treatment Period Day 1 to Day 35