Cessatech A/S announced positive topline outcome of its Phase 1 pharmacokinetics trial with CT001 in children, which met the primary endpoint of the trial. The trial was designed as a non-randomised, open-label study carried out in 25 children aged 1-17 years who needed premedication for placement of a peripheral venous catheter for general an aesthesia related to a surgical procedure.  The primary endpoint was successfully met by obtaining pharmacokinetic data in children, showing relevant clinical exposure ranges in all age groups. The pharmacokinetic data in children are needed for the planned modelling and simulation studies of CT001 (study 0207 and 0208).

Modelling and simulation studies may under the right circumstances replace traditional trials through extrapolation of e.g. efficacy from adults to children and thus a minimum of clinical trials need to be done in children during drug development.  The reported side effects were mainly of mild intensity and CT001 was considered to be safe and well tolerated in the trial. The most common side effects reported for CT001 were nausea and vomiting. There was a high acceptance rate of CT001 intranasal administration with 25 patients that received at least one dose all responded yes for acceptance, except for one who did not provide response.