NCT06391593

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alto Neuroscience · Industry
• Sex: All
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Anhedonia

Interventions

Type	Name	Description
DRUG	ALTO-203 25 μg	Active, ALTO-203 25 μg
DRUG	ALTO-203 75 μg	Active, ALTO-203 75 μg
DRUG	Placebo	Comparator, Placebo-to-match

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-04-14
• Completion: 2025-04-21
• First posted: 2024-04-30
• Last updated: 2026-04-17

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study