Drugs / HDT-321
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06799013 | Jul 2025 → Dec 2026 expected | Crimean-Congo hemorrhagic fever | HDT Bio | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-09-22 | HDT Bio | Regulatory FDA Greenlights HDT Bio’s First-in-Class HDT-321 for the Prevention of Deadly Tick-Borne Disease hdt.bio ↗
HDT Bio Corporation, a U.S.-based clinical-stage biotechnology company advancing immune-enhancing solutions for global health, biodefense, and oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HDT-321. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-09-22 | HDT Bio | FDA Greenlights HDT Bio’s First-in-Class HDT-321 for the Prevention of Deadly Tick-Borne Disease hdt.bio ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HDT-321 | “HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)” NCT06799013 ↗ |
| Modality | Small activating RNA (saRNA) | “self-amplifying RNA encoding the NP of CCHFV” NCT06799013 ↗ |
| Route | Intramuscular | “administered intra-muscularly” NCT06799013 ↗ |