CompletedPhase 1

Multiple Ascending Dose Phase 1 Study of ALA-3000

United States37 participantsStarted 2025-04-21

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female subject aged between 18 and 65 at screening visit and is able to provide informed consent prior to initiation of any study related procedures.
. At screening visit, subjects meet Diagnostic and Statistical Manual of Mental Disorders-fifth edition (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 International Neuropsychiatric Interview (MINI).
. Subject is medically stable on basis of physical examination, medical history, vital signs (blood pressure, pulse rate, respiration rate, blood oxygen saturation, and temperature), clinical laboratory tests, and 12-lead ECG performed at screening visit, and/or prior to SC administration on Day 1. Subjects with abnormalities that are judged to be not clinically significant (NCS) at the discretion of the investigator may be included. This determination must be recorded in the subject's source documents and initialed by the investigator.
. At screening visit, subjects must have insufficient response to at least 2 oral AD treatments, at least one of which is in the current episode of depression. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) will be used to assess AD treatment response during the current episode; prior medication history (e.g., medical/pharmacy/prescription records or a letter from a treating physician, etc.) will be used to determine AD treatment response in prior episode(s). If the subject's current episode of depression is \> 2 years, the upper limit of duration for assessing treatment response is applicable to only the last 2 years.
. Subject has a MADRS total score of ≥ 22 at screening.
. Male and female subjects of childbearing potential must be willing to use a reliable method of contraception (e.g., total abstinence, condom and spermicide, intrauterine device \[IUD\], oral contraception which has been stable for 30 days) during the entire trial and at least 4 months after stopping the investigational product.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment-related adverse events (AEs)

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal orthostatic blood pressure

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal heart rate

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal blood oxygen saturation (pulse oximetry)

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal respiratory rate

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal body temperature

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Trial details

NCT IDNCT06965569

SponsorAlar Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Treatment Resistant Depression trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female subject aged between 18 and 65 at screening visit and is able to provide informed consent prior to initiation of any study related procedures.
. At screening visit, subjects meet Diagnostic and Statistical Manual of Mental Disorders-fifth edition (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 International Neuropsychiatric Interview (MINI).
. Subject is medically stable on basis of physical examination, medical history, vital signs (blood pressure, pulse rate, respiration rate, blood oxygen saturation, and temperature), clinical laboratory tests, and 12-lead ECG performed at screening visit, and/or prior to SC administration on Day 1. Subjects with abnormalities that are judged to be not clinically significant (NCS) at the discretion of the investigator may be included. This determination must be recorded in the subject's source documents and initialed by the investigator.
. At screening visit, subjects must have insufficient response to at least 2 oral AD treatments, at least one of which is in the current episode of depression. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) will be used to assess AD treatment response during the current episode; prior medication history (e.g., medical/pharmacy/prescription records or a letter from a treating physician, etc.) will be used to determine AD treatment response in prior episode(s). If the subject's current episode of depression is \> 2 years, the upper limit of duration for assessing treatment response is applicable to only the last 2 years.
. Subject has a MADRS total score of ≥ 22 at screening.
. Male and female subjects of childbearing potential must be willing to use a reliable method of contraception (e.g., total abstinence, condom and spermicide, intrauterine device \[IUD\], oral contraception which has been stable for 30 days) during the entire trial and at least 4 months after stopping the investigational product.

What they're measuring

Incidence of treatment-related adverse events (AEs)

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal orthostatic blood pressure

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal heart rate

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal blood oxygen saturation (pulse oximetry)

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal respiratory rate

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Incidence of abnormal body temperature

Timeframe: Baseline (prior to dosing) through the End of Study (Day 36)/Early termination or Follow up visit

Multiple Ascending Dose Phase 1 Study of ALA-3000

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Multiple Ascending Dose Phase 1 Study of ALA-3000

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria