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HDT-321
- Development stage
- Phase 1
- Lead developer
- HDT Bio
- Modality
- mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Nanoparticles → Drug Delivery Systems, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
HDT-321 is a first-in-class prophylactic self-amplifying RNA (saRNA) vaccine being developed by HDT Bio to prevent Crimean-Congo Hemorrhagic Fever (CCHF), a tick-borne viral disease with high mortality rates. The vaccine utilizes the proprietary LION™ (Lipid Inorganic Nanoparticle) delivery system, which enhances the stability and immunogenicity of the saRNA payload without requiring ultra-cold chain infrastructure. Developed in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and the University of Texas Medical Branch (UTMB), HDT-321 received FDA Investigational New Drug (IND) clearance in September 2025. It is currently being evaluated in Phase 1 clinical trials to assess safety, reactogenicity, and immunogenicity in healthy adults.
- Other names
- HDT-321HDT321HDT 321
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