Early Stage Clinical

QPS Netherlands Completes Complex First-in-Man Antibiotic Study for US Client in Record Time

In the first quarter of 2014, QPS Netherlands completed a complex First-in-Man (FIM) study for a US Biotech company. The Single Ascending Dose (SAD), Food Effect (FE), Drug/Drug Interaction (DDI) and Multiple Ascending Dose (MAD) studies were combined under an umbrella protocol. A few highlights:

  • 6 SAD dose levels
  • DDI with 3 different drugs
  • SAD and DDI sections combined in a sequential design with 2 groups of 9 subjects
  • 3 MAD levels (10 days of dosing) with 10 subjects per dose level
  • All ~1,000,000 data points were collected within a challenging timeframe of only 2 months!

This study exemplifies safe, data-intensive and adaptive fast-forward navigation through early clinical development (ECD). To find out more about fast-track ECD, please contact Wim Tamminga, QPS Vice President and Global Head of Early Phase Clinical: wim.tamminga@qps.com

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