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MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage
Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage ...
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025","length":121,"tagName":"p"},{"type":"text","content":"MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date.","length":691,"tagName":"p"},{"type":"text","content":""Completion of the SAD portion with a favorable safety and tolerability profile is an important milestone in the clinical development of Ketamir-2," said Prof. Yoseph Caraco, Principal Investigator of the Phase 1 study. "Importantly, no severe or clinically significant adverse effects have been observed to date, which supports continued progression into the Multiple Ascending Dose stage of the trial."","length":424,"tagName":"p"},{"type":"text","content":"Phase 1 Study Overview","length":22,"tagName":"p"},{"type":"text","content":"The study- "A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects"-is designed to establish the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers.","length":365,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Design: Single-center, randomized, double-blind, placebo-controlled SAD/MAD with sentinel dosing and Safety Steering Committee (SSC) reviews between cohorts.","length":157,"tagName":"p"}]},{"val":[{"type":"text","content":"SAD completed: Four cohorts (single doses 50 mg to 600 mg); 32 participants treated (male and female).","length":102,"tagName":"p"}]},{"val":[{"type":"text","content":"Safety monitoring: Extensive central nervous ...