Patrys (ASX: PAB) has received Human Research Ethics Committee (HREC) approval to begin its Phase 1A clinical trial of RLS-2202, a candidate being developed for the treatment of delirium in acute care settings.

The Phase 1A study is designed to assess the safety, tolerability and pharmacokinetics of RLS-2202 in healthy volunteers. The trial is expected to generate dosing information that will inform later stages of clinical development.

Receipt of HREC approval follows completion of the required regulatory and preparatory activities and marks an important milestone in the development of RLS-2202.

With ethics approval now in place, Patrys will move ahead with clinical site activation and other remaining study start-up activities before first participant dosing, which the company said remains on track for this quarter.

Patrys said it continues to work with its manufacturing, bioanalytical, clinical site and contract research organisation partners to ensure the study is conducted to high standards of quality, safety and scientific rigour.

Chief executive Dr Samantha South said the approval was a significant step forward and reflected the progress being made across the program.

“We are now focused on initiating the study, recruiting participants and generating data to support the next stages of clinical development for RLS-2202,” Dr South said.

“With first participant dosing expected this quarter, we look forward to providing shareholders with further updates as the study progresses.

“Delirium remains a significant unmet medical need, and we look forward to advancing this important clinical program.”

The approval allows Patrys to proceed with its Phase 1A bridging study evaluating the safety, tolerability and pharmacokinetics of RLS-2202 following intravenous and oral administration in healthy adult volunteers.

The study will use a sequential dose-escalation design, with progression between the two cohorts subject to review by an independent Safety Review Committee in line with the study protocol.

The primary objective of the trial is to assess the safety and tolerability of RLS-2202. Secondary objectives include evaluating the pharmacokinetic profile and identifying dose levels to support subsequent clinical development.

Data from the study will be used to support dose selection and the design of later clinical trials.

Patrys said it will now complete the remaining study start-up activities. The company expects first participant dosing to occur this quarter.

Delirium is a sudden, severe change in brain function that causes confusion, trouble focusing and rapid mental shifts. In Australia, it affects up to 18% of hospital patients aged 65 and older.