Phase I clinical trial design
ICH
STERILITY
In a first‐in‐human study, a phase I clinical trial in which healthy volunteers were enrolled to assess the safety of human allogeneic pEVs manufactured through the LEAP protocol was conducted (Plexoval II study, ACTRN12620000944932). LEAP isolation of clinical‐grade pEVs was conducted under GMP‐like protocols, performed in an ISO5 BioSpherix GMP Isolator Unit housed in an ISO8 certified clean room. Prior to release for human use, quality control in the form of sterility testing, endotoxin testing, and particle and protein concentration analysis, was performed.Plexoval II was a prospective, randomised, double‐blind, placebo‐controlled, single dose, single site clinical trial conducted in Melbourne, Australia. The study was conducted following Good Clinical Practice guidelines, and applicable regulatory requirements, including the Declaration of Helsinki and the ICH harmonised tripartite guideline. Ethics approval was granted by the Bellberry Human Research Ethics Committee, Eastwood, South Australia (ethics approval number HREC2020‐07‐622).Only healthy volunteers that met the specified inclusion and exclusion criteria were able to participate in this study (Table 