Drugs / SBT115301
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05388981 | Jul 2022 → Jan 2024 | — | Sonoma Biotherapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-06-08 | Sonoma Biotherapeutics, Inc. | Regulatory Sonoma Biotherapeutics Announces FDA Clearance of Investigational New Drug Application for SBT115301, an Effector T Cell-Modulating Biologic for Autoimmune Diseases sonomabio.com ↗
Sonoma Biotherapeutics, an immune tolerance company focused on the development of novel regulatory T cell (T reg ) therapies for autoimmune and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 study of SBT115301 in healthy participants. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-06-08 | Sonoma Biotherapeutics, Inc. | Sonoma Biotherapeutics Announces FDA Clearance of Investigational New Drug Application for SBT115301, an Effector T Cell-Modulating Biologic for Autoimmune Diseases sonomabio.com ↗ |
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 | SBT115301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05388981 ↗ |
| Modality | Protein / enzyme biologic | “Immunomodulatory dimeric fusion protein” NCT05388981 ↗ |
| Route | Intramuscular | “Intramuscular (IM) dose level 1” NCT05388981 ↗ |