Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has received Human Research Ethics Committee (HREC) approval for the company’s planned pharmacokinetic (PK) study in healthy human adult participants to be conducted at CMAX Clinical Research, Adelaide, South Australia.
“We are pleased to secure this important HREC approval, which now allows us to commence this PK study of NTI164,” Dr Thomas Duthy, Executive Director of Neurotech, said.
“Although we have demonstrated long term safety and efficacy of NTI164 in paediatric patients across three separate neurological disorders, a PK study is a requirement for global health regulators, including the US Food and Drug Administration as part of an Investigational New Drug (IND) approval and the Australian Therapeutic Goods Administration as part of the necessary documentation to fulfil the requirements under an accelerated provisional application pathway.
“The study is expected to commence during the current quarter with results in Q1 CY2025. In parallel, we are currently conducting repeat-dose toxicity studies across two animal species, which we also expect to complete during Q1 CY2025 and also represents an important requirement for regulators.”
The PK study will generate important clinical data on the metabolism and excretion of NTI164 in an adult human population. This study will use two biological matrices (blood (plasma) and urine), collected at various time points. This study will be split into 2 parts, Part A and Part B. In both Parts, NTI164 will be delivered orally, twice daily, at a dose of 20mg/kg/day. In both Parts, blood and urine samples will be collected before the first dose of NTI164.
Four participants will receive a 20mg/kg of NTI164 split into two doses of NTI164 approximately 12 hours apart (Part A), followed by eight participants who will receive NTI164 for seven consecutive days (Part B) using the same regimen as Part A.