Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391593
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-08
Brief Title:
PD PK and Safety of ALTO-203 in Patients With MDD
Sponsor:
Alto Neuroscience
Organization:
Alto Neuroscience
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None