Nyrada Inc (ASX:NYR) Initiates Phase Ia Clinical Trial
HREC Approval
Nyrada Inc (ASX:NYR) has received approval from the Human Research Ethics Committee (HREC) to initiate its first-in-human Phase Ia clinical trial. The trial will assess the safety, tolerability, and pharmacokinetics of lead drug candidate NYR-BI03 in healthy human volunteers.
Trial Details
The double-blind, randomised, placebo-controlled, dose escalating study will consist of five cohorts of eight healthy volunteers each, with six receiving NYR-BI03 and two receiving placebo per cohort. Volunteer recruitment is set to begin shortly, with the first dosing anticipated by the end of March 2025. Final Phase Ia trial readouts are expected in the third quarter of CY2025. Safety assessments will include monitoring for adverse events, blood tests, physical examinations, and cardiac function.
Executive Comments
CEO James Bonnar stated, “HREC approval is a very exiting outcome as Nyrada transitions from a pre-clinical to a clinical company. The successful completion of this Phase Ia study opens the door to further clinical development across multiple indications. I am very proud of the excellent work and dedication of the dedicated Nyrada team.”
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