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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) is sponsored by National Institutes of Health. Funds early stage trials of new drugs and neuromodulatory devices for psychiatric disorders, aiming to de-risk and attract further funding.
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gov Maintenance Calendar View similar opportunities 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 National Institutes of Health Document Type:Grants Notice Funding Opportunity Number:PAR-25-180 Funding Opportunity Title:First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) Opportunity Category:Discretionary Opportunity Category Explanation: Funding Instrument Type:Cooperative Agreement Category of Funding Activity:Health Expected Number of Awards: Assistance Listings:93.
242 -- Mental Health Research Grants Cost Sharing or Matching Requirement:No Last Updated Date:Nov 27, 2024 Original Closing Date for Applications:Oct 15, 2027 Current Closing Date for Applications:Oct 15, 2027 Archive Date:Nov 20, 2027 Estimated Total Program Funding: Eligible Applicants:For profit organizations other than small businesses Special district governments Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) City or township governments Additional Information on Eligibility: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.
## Additional Information Agency Name:National Institutes of Health 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. Link to Additional Information:https://grants. nih.
gov/grants/guide/pa-files/PAR-25-180. html Grantor Contact Information:If you have difficulty accessing the full announcement electronically, please contact: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
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According to the current listing, eligibility includes: Nonprofits, universities, state/local governments, private institutions of higher education, public housing authorities, Native American tribal organizations, and IHEs. Confirm the full requirements in the official notice before applying.
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required) is funded by National Institutes of Health. Verify program details on the funder's official page before applying.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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