This opportunity funds investigator-initiated Phase I clinical trials for diagnostic and therapeutic interventions addressing heart, lung, blood, and sleep disorders in adults and children. It supports clinical trial start-up, implementation, and final stage preclinical activities essential for trial readiness. The award uses a bi-phasic, milestone-driven mechanism, allowing the first phase to finalize pre-trial activities such as stability and shipping studies and site training. Trials may be single or multisite.
Eligible applicants include a wide range of organizations such as public housing authorities, institutions of higher education, small businesses, government entities, nonprofits, tribal organizations, and certain foreign entities. Specific eligibility details are provided in the full announcement.