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

Alto Neuroscience

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Anhedonia

Treatments: Drug: ALTO-203 25 μg; Drug: Placebo; Drug: ALTO-203 75 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06391593

ALTO-203-201

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Evidence of unstable medical condition
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Concurrent use of prohibited medications
• Current moderate or severe substance use disorder
• Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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69 participants in 3 patient groups, including a placebo group

ALTO-203 25 μg

Experimental group

Description:

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

Treatment:

Drug: ALTO-203 25 μg

ALTO-203 75 μg

Experimental group

Description:

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

Treatment:

Drug: ALTO-203 75 μg

Placebo

Placebo Comparator group

Description:

Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days

Treatment:

Drug: Placebo