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AIMRecent publications indicate a strong interest in applying Bayesian adaptive designs in first time in humans (FTIH) studies outside of oncology. The objective of the present work was to assess the performance of a new approach that includes Bayesian adaptive design in single ascending dose (SAD) trials conducted in healthy volunteers, in comparison with a more traditional approach. METHODSA trial simulation approach was used and seven different scenarios of dose-response were tested. RESULTSThe new approach provided less biased estimates of maximum tolerated dose (MTD). In all scenarios, the number of subjects needed to define a MTD was lower with the new approach than with the traditional approach. With respect to duration of the trials, the two approaches were comparable. In all scenarios, the number of subjects exposed to a dose greater than the actual MTD was lower with the new approach than with the traditional approach. CONCLUSIONSThe new approach with Bayesian adaptive design shows a very good performance in the estimation of MTD and in reducing the total number of healthy subjects. It also reduces the number of subjects exposed to doses greater than the actual MTD. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Bayesian adaptive designs in phase 1 oncology trials have been used for more than two decades.• Outside of oncology, these model-based approaches are very rarely used in phase 1 studies.• Recent publications indicate an interest to find better and more efficient approaches in the conduct of single ascending dose trials. WHAT THIS STUDY ADDS• An approach with Bayesian adaptive design shows a very good performance in the estimation of maximum tolerated dose (MTD) and in reducing the total number of healthy subjects.• This approach reduces the number of subjects exposed to doses greater than the actual MTD.