Alar Pharmaceuticals, a Taiwan-based clinical-stage company listed on the TPEx exchange, reported Phase I results for ALA-3000, a subcutaneous sustained-release ketamine formulation, in treatment-resistant depression, with the company saying the first-in-human study met its primary endpoint of safety and tolerability while generating exploratory efficacy signals across a 36-day observation window.
In the randomized, double-blind, placebo-controlled study, patients received two subcutaneous injections of ALA-3000 at either 150 mg or 250 mg, or placebo, administered one week apart, alongside a daily oral antidepressant. Treatment-related adverse events were mild to moderate in severity; the most frequently reported across both active and placebo groups were injection site reactions, headache, and diarrhea, all described as transient. No subjects discontinued due to adverse events. The company reported no clinically meaningful blood pressure elevations, no signals related to abuse potential, and no urinary adverse events. Mean Clinician-Administered Dissociative States Scale scores remained at or below 0.7 across active dose groups, comparable to placebo, with no dissociation-related adverse events reported. All subjects remained fully alert throughout the study period.
Pharmacokinetic data showed gradual increases in plasma ketamine concentrations without pronounced peak levels and no dose dumping, with exposure described as steady across the study period. On exploratory efficacy endpoints assessed by the Montgomery–Åsberg Depression Rating Scale, the company reported separation from placebo from Day 9 onward, with the 150 mg group showing approximately 3 to 6 points greater MADRS reduction versus placebo between Days 9 and 36, and the 250 mg group showing approximately 2 to 4 points greater reduction over the same interval. Response rates from Day 11 to Day 36 reached at least 60% for the 150 mg group and 54% to 69% for the 250 mg group, compared with 36% to 45% for placebo. Remission rates from Day 22 to Day 36 were 50% for the 150 mg group and 23% to 31% for the 250 mg group, versus 18% for placebo.