First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Jun 15, 2024

Later deadlines: Oct 15, 2024

Grant amount: Unspecified amount

Fields of work: Mental Health & Psychiatric Diseases Pharmacology

Applicant type: Government Entity, Indigenous Group, Nonprofit, For-Profit Business

Funding uses: Research

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Overview:

NOTE: All applications are due by 5:00 PM local time of applicant organization. Optional but encouraged Letters of Intent are due 30 days prior to the full proposal deadline. 


The purpose of this Funding Opportunity Announcement (FOA) 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 FOA 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 FOA 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 FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed January 18, 2024 and last updated January 18, 2024