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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 is a Phase 2 study that has completed, run by Alto Neuroscience. The registered enrollment target is 69 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06391593
The ClinicalTrials.gov registry entry for NCT06391593 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alto Neuroscience, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06391593 reports 0 study locations.
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.
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