First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Department of Health and Human Services
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impac
Funding
Award size
Not specified
Type
Cooperative Agreement
Dates
Deadline
Later
Posted
11/26/2024
Closes
2027-10-15
Eligibility
Eligibility
Private institutions of higher educationNative American tribal governments (Federally recognized)Others (see text field entitled "Additional Information on Eligibility" for clarification)For profit organizations other than small businessesCounty governmentsNative American tribal organizations (other than Federally recognized tribal governments)Independent school districtsCity or township governmentsSpecial district governmentsPublic and State controlled institutions of higher educationPublic housing authorities/Indian housing authoritiesNonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher educationState governmentsNonprofits having a 501(c)(3) status with the IRS, other than institutions of higher educationSmall businesses
Program
Funding area
Health - HL
Opportunity #
PAR-25-180
Source
Status
Open
Market
Government
Level
Federal
Source
Grants.gov