Trials / Completed
CompletedNCT06965569
Multiple Ascending Dose Phase 1 Study of ALA-3000
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of ALA-3000, Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Subjects With Treatment-Resistant Depression (TRD)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Alar Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | ALA-3000 | Subcutaneous injection |
| DRUG | Placebo | 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 |
Timeline
- Start date
- 2025-04-21
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2025-05-11
- Last updated
- 2025-12-31
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06965569. Inclusion in this directory is not an endorsement.