Mira Pharmaceuticals Inc. reported it has completed dosing in a Phase 1 randomized, double-blind, placebo-controlled trial of Ketamir-2, an oral selective NMDA receptor modulator, in 56 healthy volunteers. The study included single ascending doses from 50 mg to 600 mg and multiple ascending doses of 150 mg, 300 mg, or 600 mg daily for five days; the company said no serious adverse events or dose-limiting toxicities were reported to date, and final pharmacokinetic and safety analyses are underway following database lock and unblinding. Mira said it plans to submit a Phase 2a study package to the FDA under its active IND in the first half of 2026 for a proof-of-concept trial in patients with moderate to severe chemotherapy-induced peripheral neuropathy. The company stated that Phase 1 data will be presented at an upcoming scientific meeting.
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