NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
Supporting early phase clinical trials for heart, lung, blood, and sleep disorders in both adults and children, with applicants expected to be ready to start trials within the initial project period.
Funder: National Institutes of Health
Due Dates: February 3, 2027 (Final application deadline)
Funding Amounts: Up to $1,515,000 in direct costs per year for up to 3 years; no cost sharing required
Summary: Supports investigator-initiated Phase I clinical trials of therapeutics and diagnostics for heart, lung, blood, and sleep disorders.
Key Information: Trials should begin within the first project quarter, with applicable approvals, product supplies, and third-party agreements established by award.
Description
The National Heart, Lung, and Blood Institute (NHLBI) supports investigator-initiated Phase I clinical trials of diagnostic and therapeutic interventions for heart, lung, blood, and sleep disorders in adults and children. Eligible interventions include drugs, devices, biologics, cells, and cell products. Trials may be single-site or multisite, including bridging studies that extend existing clinical data to a new population, such as children.
This milestone-driven R33 program aims to accelerate early translational research and development of new clinical interventions. The primary aim is product safety; secondary aims may address feasibility, acceptability, dose-response, pharmacokinetics, biological signatures, or outcome measures for later trials. Projects needing support for preclinical work or trial-readiness activities should consider the companion R61/R33 opportunity, PAR-25-026.
