Phase I Hybrid Trials - A guide to successful planning and execution

Phase I hybrid trials are early clinical studies combining both healthy normal volunteers (HNVs) and patients from the target indication in one protocol. These trials can be extraordinarily valuable, as they can deliver important insights regarding a drug's pharmacodynamic (PD) effects and therapeutic potential at a very early stage in development. Traditionally, HNV and patient populations were enrolled in sequential studies, referenced as Phase Ia (including HNVs) and Phase Ib (including patients), respectively. Given that our industry has witnessed a steadily increasing interest in these types of combined trials over the past three to five years, this white paper provides an overview of hybrid trial background and feasibility, and discusses considerations around potential value, study design options, biomarker strategies and regulatory aspects with a few case studies to illustrate the successful execution of hybrid studies.