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First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)

National Institutes of Health Nonprofit eligible

Administered by National Institutes of Health, this health grant invites applications from nonprofits and other eligible applicants, with applications due Oct 15, 2027.

See full details on Grants.gov
Deadline
Oct 15, 2027
Posted
Nov 26, 2024
Opportunity number
PAR-25-180
CFDA
93.242

Opportunity description

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 impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

Who can apply

  • For profit organizations other than small businesses
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Native American tribal governments (Federally recognized)
  • Special district governments
  • State governments
  • City or township governments
  • County governments
  • Private institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Public and State controlled institutions of higher education
  • Small businesses
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Independent school districts

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Agency contact

National Institutes of Health

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Where to apply

Applications go through Grants.gov directly. We recommend reading the full announcement and double-checking eligibility and dates on the official listing first.

Official Grants.gov listing

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