Case Study
Irritating Intravenous Dosing Fully Leverages Spaulding’s Decentralized Clinical Research Unit Design
Spaulding Clinical conducted a randomized, double-blind study that evaluated the safety, tolerability, and pharmacokinetics of 7-day intravenous regimen of a novel next-generation antibiotic. An open-label evaluation followed, which included a 1-day sequential oral dose followed by an intravenous dose in healthy adult subjects. As background, the biotechnology sponsor shared that previous formulations had a significant adverse event (AE) profile, so the sponsor required the elimination of inter-subject influence during dosing; they wanted all subjects dosed in separate rooms.