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Multiple Ascending Dose Phase 1 Study of ALA-3000

NCT06965569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-31

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multiple-dose study of ALA-3000 designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in subjects with treatment-resistant depression (TRD).

Conditions

Interventions

DRUG

Placebo

Subcutaneous injection

DRUG

ALA-3000

Subcutaneous injection

DRUG

escitalopram, sertraline, duloxetine or venlafaxine XR

Newly initiated oral AD selected from SSRI (escitalopram or sertraline) or SNRI (duloxetine or venlafaxine XR) will be given daily

Sponsors & Collaborators

  • Alar Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965569 on ClinicalTrials.gov