Grant opportunity · PAR-25-180
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Who can apply (as listed)
- County governments
- Private institutions of higher education
- City or township governments
- State governments
- Native American tribal organizations (other than federally recognized governments)
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- Public housing authorities / Indian housing authorities
- Native American tribal governments (federally recognized)
- Others (see the opportunity text)
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Small businesses
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations (other than small businesses)
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 col…
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