4. Sequence and Interval Between Dosing of Participants

  1. Usually, a single participant receives a single dose of the active investigational medicine.

  2. Further dose administration should be sequential within each cohort to mitigate the risk.

  3. There must be an adequate period of observation between the administration of the medicinal product to the first, second and subsequent participants in a cohort to observe and interpret reactions.

  4. Administration in the next cohort should not occur before participants in the previous cohort have been treated and data/results from those participants are reviewed.