First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings: 93.242 -- Mental Health Research Grants
Last Updated: November 27, 2024
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.
Eligibility
Eligible applicants
Government
- County governments
- Public and Indian housing authorities
- Federally recognized Native American tribal governments
- State governments
- City or township governments
- Special district governments
Education
- Private institutions of higher education
- Public and state institutions of higher education
- Independent school districts
Miscellaneous
- Other
Nonprofit
- Nonprofits non-higher education without 501(c)(3)
- Nonprofits non-higher education with 501(c)(3)
- Other Native American tribal organizations
Business
- Small businesses
- For-profit organizations other than small businesses
Additional information
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.
Grantor contact information
Description
NIH Grants Information
grantsinfo@nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Documents
| File name | Description | Last updated |
|---|---|---|
| PAR-25-180-Full-Announcement.html | PAR-25-180 Full Announcement Text | Nov 27, 2024 03:19 PM UTC |
Link to additional information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-180.html
Closing: October 15, 2027
Award
$--
Program Funding
--
Expected awards
$--
Award Minimum
$--
Award Maximum
Funding opportunity number:
PAR-25-180
Cost sharing or matching requirement:
No
Funding instrument type:
Cooperative agreement
Opportunity Category:
Discretionary
Opportunity Category Explanation:
--
Category of Funding Activity:
Health
Category Explanation:
--
History
Version:
1
Posted date:
November 26, 2024
Archive date:
November 20, 2027
