other_material
confidence high
sentiment positive
materiality 0.70
MIRA Pharma Phase 1 SAD of Ketamir-2 safe, well tolerated; positive PK
MIRA PHARMACEUTICALS, INC.
- Phase 1 SAD study in 32 healthy volunteers (50-600 mg doses) showed no severe or serious adverse events.
- Dose-proportional exposure (Cmax, AUC); median Tmax 1-2 h; half-life 2-5 h; metabolite nor-Ketamir half-life 6.5-8.5 h.
- Company to initiate MAD portion of Phase 1, followed by Phase 2a trial in neuropathic pain patients.
- DEA concluded Ketamir-2 is not a controlled substance under the Controlled Substances Act.
item 8.01