This funding supports investigator-initiated phase I clinical trials for diagnostic and therapeutic interventions addressing heart, lung, blood, and sleep disorders in adults and children. Trials may be single or multisite and require readiness to start within the first quarter of the project. Applicants must have regulatory approvals and drug/placebo supplies established by award time. Pre-clinical activities should be pursued via a companion phased NOFO.
Eligible applicants include a wide range of organizations such as government entities, higher education institutions, nonprofits, for-profit organizations, tribal governments, and small businesses. Non-domestic entities are not eligible, but foreign components of U.S. organizations are allowed.