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
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 64
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Site 4058
RECRUITING
Tucson
California
Site 4082
RECRUITING
Oceanside
Site 4023
RECRUITING
Torrance
Florida
Site 4059
RECRUITING
Clermont
Site 4005
RECRUITING
Orlando
Georgia
Site 4031
RECRUITING
Atlanta
Maryland
Site 4054
RECRUITING
Pikesville
New Jersey
Site 4022
RECRUITING
Berlin
Site 4134
RECRUITING
Princeton
Nevada
Site 4036
RECRUITING
Las Vegas
Ohio
Site 4075
NOT_YET_RECRUITING
Westlake
Texas
Site 4040
RECRUITING
Austin
Site 4072
RECRUITING
Houston
Utah
Site 4007
RECRUITING
Clinton
Washington
Site 4033
RECRUITING
Bellevue
Contact Information
Primary
Alto Neuroscience
clinical@altoneuroscience.com
650-200-0412
Time Frame
Start Date:2024-03-25
Estimated Completion Date:2025-05
Participants
Target number of participants:60
Treatments
Experimental: ALTO-203 25 μg
Drug: ALTO-203 25 μg~Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg~Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days
Experimental: ALTO-203 75 μg
Drug: ALTO-203 75 μg~Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg~Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days
Placebo_comparator: Placebo
Drug: Placebo~Single-Dose Treatment Period: Single Dose, Placebo~Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days