MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site [Yahoo! Finance]
MIRA Pharmaceuticals, Inc. (MIRA)
Company Research
Source: Yahoo! Finance
Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2. (Source: 'MIRA Accelerates Toward Becoming a Clinical-Stage Company...') The Phase I/IIa trial is structured as a randomized, double-blind, placebo-controlled study conducted in two parts: Phase I will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects, while Phase IIa will focus on diabetic neuropathy patients to generate efficacy data. The trial will utilize CHDR's proprietary PainCart technology to measure pain response. (Source: 'Innovative Study Design Focused on Early Proof-of-Concept Data') Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025. The Phase IIa study is planned to start in Q4 2025, with initial human efficacy results anticipated in the first half of 2026. (Source: 'MIRA Accelerates Toward Becoming a Clinical-Stage Company...') MI
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MIRA
News
- MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain [Yahoo! Finance]Yahoo! Finance
- MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development [Yahoo! Finance]Yahoo! Finance
- MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline DevelopmentAccesswire
MIRA
Sec Filings
- 3/4/25 - Form 8-K
- 12/20/24 - Form 8-K
- 12/19/24 - Form 8-K
- MIRA's page on the SEC website