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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, ALA-3000, for individuals with treatment-resistant depression (TRD). Researchers seek to determine if this drug is safe and effective when other depression treatments have failed. Participants will receive either a low or high dose of ALA-3000 or a placebo, alongside an oral antidepressant. Suitable candidates have major depressive disorder (MDD) and have not responded to at least two antidepressants. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects on people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that subjects taking a high dose of benzodiazepines or those on prohibited therapies are excluded, so you may need to discuss your specific medications with the trial team.

Is there any evidence suggesting that ALA-3000 is likely to be safe for humans?

Research shows that ALA-3000 is being explored as a new treatment for people with depression that hasn't responded to other treatments. Early studies have examined its safety and tolerability. ALA-3000 is a type of ketamine, already used in other treatments and known for its rapid action.

Although detailed safety data from these studies is not yet available, the FDA's approval for testing ALA-3000 suggests promise in early safety evaluations. This clinical trial is in its first phase, focusing primarily on assessing the treatment's safety in humans. This phase typically marks the first human testing of the drug, so safety information is still being gathered.

In summary, ALA-3000 is in the early stages of research, with its safety under careful observation. Approval for human testing indicates initial confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Unlike the standard antidepressants that primarily work by altering neurotransmitter levels over weeks, ALA-3000 offers a potentially faster approach by using subcutaneous injections. This treatment is unique because it targets the condition with both low and high-dose options, aiming to optimize its effectiveness and reduce the time it takes to feel better. Researchers are excited about ALA-3000 because it promises quicker relief from depression symptoms, potentially improving the quality of life for patients who need fast-acting solutions.

What evidence suggests that ALA-3000 might be an effective treatment for depression?

Research suggests that ALA-3000 might help people with depression unresponsive to other treatments. Early studies show that ALA-3000 may manage depression by affecting certain brain chemicals that control mood. Although limited information exists from human studies, these findings indicate that ALA-3000 could offer a new option for those without relief from other treatments. Initial results from similar research are promising, but further studies are needed to confirm these findings. ^{1 2 4 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06965569

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 ...

2. alarpharm.com alarpharm.com/2024-12-14-alar-announced-that-a-phase-i-clinical-trial-of-ala-3000-injection-in-treatment-resistant-depression-patients-has-been-approved-by-the-us-fda/

2024/12/14 Alar announced that a Phase I clinical trial ... Alar announced that a Phase I clinical trial of ALA-3000 Injection in treatment-resistant depression patients has been approved by the US FDA.

3. withpower.com withpower.com/trial/phase-1-depression-3-2025-52548

ALA-3000 for Depression This is a randomized, double-blind, placebo-controlled, multiple-dose study of ALA-3000 designed to evaluate the safety, tolerability, pharmacokinetics and ...

4. synapse.patsnap.com synapse.patsnap.com/drug/04c1f0f74642407896a6eabaca32c362

ALA-3000 - Drug Targets, Indications, Patents A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of ALA-3000, Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary ...

5. withpower.com withpower.com/clinical-trials/for-treatment-resistant-depression

Top Treatment Resistant Depression Clinical Trials | Power This is a randomized, double-blind, placebo-controlled, multiple-dose study of ALA-3000 designed to evaluate the safety, tolerability, pharmacokinetics and ...

6. biospace.com biospace.com/press-releases/alar-pharmaceuticals-announces-first-patient-dosing-in-a-study-of-ala-3000-extended-release-ketamine-injection-for-treatment-resistant-depression-trd

Alar Pharmaceuticals Announces First Patient Dosing in a ... ALA-3000, developed by Alar Pharmaceuticals, is the first formulation of ketamine lasting over one week in the blood following single dose.

7. finance.yahoo.com finance.yahoo.com/news/alar-pharmaceuticals-announces-first-patient-120000362.html

Alar Pharmaceuticals Announces First Patient Dosing in a ... ALA-3000, developed by Alar Pharmaceuticals, is the first formulation of ketamine lasting over one week in the blood following single dose. It ...