Sample size determination
PD
Formal sample size calculations were not performed however with a total sample size of 18 healthy volunteers and a given incidence of a specific common AE of 1% in the general population the study would be able to detect an additional incidence of such AE caused by the use of the new drug of 11% with a power of 80%. Given the stage of development and the objective to determine the safety, PK and PD profiles of MRG-001, 12 subjects were considered adequate to assess the safety and PK/PD profiles in this initial part of development.