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NCT06965569 · ClinicalTrials.gov registry record · Phase 1

Multiple Ascending Dose Phase 1 Study of ALA-3000

A Phase 1 study of Treatment-Resistant Depression, sponsored by Alar Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target
4
Study locations

NCT06965569 is a Phase 1 study of Treatment-Resistant Depression that has completed, run by Alar Pharmaceuticals. The registered enrollment target is 37 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT06965569, a Phase 1 study of Treatment-Resistant Depression, has completed, sponsored by Alar Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target
4
Study locations

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).

Interventions

  • DRUG Placebo
  • DRUG ALA-3000
  • DRUG escitalopram, sertraline, duloxetine or venlafaxine XR

Study Locations (4)

Arkansas

  • Pillar Clinical Research - Little Rock

Missouri

  • Arch Clinical Trials - St Louis

New Jersey

  • Clinilabs Drug Development Corporation - Eatontown

Ohio

  • Neuro-Behavioral Clinical Research, Inc - North Canton

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2025-04-21
Est. Completion 2025-12-30
Phase Phase 1

Sponsor

Alar Pharmaceuticals

2 total trials

What the Registry Record Tells You About NCT06965569

The ClinicalTrials.gov registry entry for NCT06965569 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (90% lower). The listed sponsor is Alar Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06965569 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Arkansas, Missouri, New Jersey.

Frequently Asked Questions

What is clinical trial NCT06965569 about?

NCT06965569 is a clinical study titled "Multiple Ascending Dose Phase 1 Study of ALA-3000". 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).

What is the current status of trial NCT06965569?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2025-04-21. Estimated completion is 2025-12-30.

What conditions does trial NCT06965569 study?

This clinical trial studies the following conditions: Treatment-Resistant Depression.

What interventions are being tested in trial NCT06965569?

The interventions under investigation include: Placebo (DRUG), ALA-3000 (DRUG), escitalopram, sertraline, duloxetine or venlafaxine XR (DRUG).

Who is sponsoring clinical trial NCT06965569?

This trial is sponsored by Alar Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06965569 being conducted?

This trial has 4 study locations across Arkansas, Missouri, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.