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NCT06391593 · ClinicalTrials.gov registry record · Phase 2
PD, PK, and Safety of ALTO-203 in Patients With MDD
A Phase 2 study, sponsored by Alto Neuroscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT06391593: Completed Phase 2 study, sponsored by Alto Neuroscience.
NCT06391593 is a Phase 2 study that has completed, run by Alto Neuroscience. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06391593, a Phase 2 study, has completed, sponsored by Alto Neuroscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG ALTO-203 25 μg
- DRUG ALTO-203 75 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2025-04-21 |
| Phase | Phase 2 |
What the finished NCT06391593 record still lists
NCT06391593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06391593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06391593 about?
NCT06391593 is a clinical study titled "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-do...
What is the current status of trial NCT06391593?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2024-03-25. Estimated completion is 2025-04-21.
What interventions are being tested in trial NCT06391593?
The interventions under investigation include: Placebo (DRUG), ALTO-203 25 μg (DRUG), ALTO-203 75 μg (DRUG).
Who is sponsoring clinical trial NCT06391593?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06391593's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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