Drugs / ISU304
ISU304
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03186677 | Jun 2017 → Oct 2018 | hemophilia B | ISU Abxis Co., Ltd. | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ISU304 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03186677 ↗ |
| Known as | CB2679d | “This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of ISU304/CB2679d/Dalcinonacog alfa...” NCT03186677 ↗ |
| Known as | DalcA | “Dalcinonacog alfa (DalcA), a novel subcutaneously administered recombinant human factor IX (FIX) variant is being developed for adult and paediatric patients with hemophilia B (HB).” PMID 37341915 ↗ Jun 2023 |
| Action | Restore | “DalcA has been shown to raise FIX to clinically meaningful levels in adults with HB.” PMID 37341915 ↗ Jun 2023 |
| Modality | Protein / enzyme biologic | “Dalcinonacog alfa (DalcA), a novel subcutaneously administered recombinant human factor IX (FIX) variant” PMID 37341915 ↗ Jun 2023 |
| Route | Intravenous | “Each cohort may receive an intravenous administration of 75 IU/kg” NCT03186677 ↗ |