ALA-3000 for Depression

Overseen By Alar Pharmaceuticals Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alar Pharmaceuticals Inc.

Must be taking: Antidepressants

Must not be taking: Benzodiazepines, Barbiturates, others

Disqualifiers: Liver disease, Hypertension, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for individuals with treatment-resistant depression, meaning their condition didn't improve after trying other medications. Participants must meet specific health criteria to join.

Inclusion Criteria

Female subjects of childbearing potential must have a negative serum β-hCG at screening visit and a negative urine pregnancy test prior to SC administration on Day 1

Agree to adhere to the prohibitions and restrictions specified in this protocol

At screening visit, subjects meet DSM-5 criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI

Exclusion Criteria

Subject has AST or ALT ≥ 2 × ULN or total bilirubin > 1.5 × ULN

Subject has known allergies, hypersensitivity, intolerance, or contraindication to specific medications

Subjects are pregnant or lactating or planning to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two subcutaneous injections of ALA-3000 or placebo on Day 1 and Day 8, along with daily open-label oral antidepressants

4 weeks

2 visits (in-person) for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of injection site tolerability and various clinical measures

4 weeks

1 visit (in-person) at the end of study

What Are the Treatments Tested in This Trial?

Interventions

• ALA-3000

Trial Overview The study tests multiple doses of a new drug called ALA-3000 against a placebo and compares it with existing antidepressants like escitalopram, sertraline, duloxetine or venlafaxine XR in people with TRD.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 3 Interventions

Subjects received two subcutaneous injections of "high-dose" ALA-3000 or matching volume of Placebo on Day 1 and Day 8. During the treatment period, all subjects will receive a newly initiated open-label oral antidepressants daily.

Group II: Cohort 1 Experimental Treatment 3 Interventions

Subjects received two subcutaneous injections of "low-dose" ALA-3000 or matching volume of Placebo on Day 1 and Day 8. During the treatment period, all subjects will receive a newly initiated open-label oral antidepressants daily.

Who Is Running the Clinical Trial?

Alar Pharmaceuticals Inc.

Lead Sponsor

Trials

1

Recruited

60+