Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISU304/CB2679d/Dalcinonacog alfa 75~/kg · 1 trial · 1 indication
The number of reported AEs (local/systemic/other) after IP administration was calculated by cohort.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation |
| Cohort 2 | EXPERIMENTAL | Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation |
| Cohort 3 | EXPERIMENTAL | Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation |
| Cohort 4 | EXPERIMENTAL | One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation |
| Cohort 5 | EXPERIMENTAL | One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed by subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation |
| Name | Type | Description |
|---|---|---|
| ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg | BIOLOGICAL | ISU304/CB2679d/Dalcinonacog alfa 75\~150 IU/kg by intravenous or subcutaneous |
| BeneFIX | BIOLOGICAL | BeneFIX 75 IU/kg, intravenous administration |
Inclusion Criteria: 1. Previously treated male patients with moderate or severe hemophilia B (documented FIX activity ≤ 2% and exposed to any FIX product for ≥ 150 exposure days (estimated) at the time of screening) 2. Patients must be 12 to 65 years old at the time of screening 3. Patients who hav...
ISU304/CB2679d/Dalcinonacog alfa is an investigational drug being developed for the treatment of Hemophilia B. It is a monoclonal antibody being studied in clinical trials to evaluate its safety and pharmacological properties in patients with this condition.
ISU304/CB2679d/Dalcinonacog alfa is being developed by Catalyst Pharmaceuticals, Inc., a company publicly traded under the ticker symbol CPRX. The drug is currently in clinical development for Hemophilia B.
ISU304/CB2679d/Dalcinonacog alfa is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety, pharmacokinetics, and pharmacodynamics in patients with Hemophilia B.
ISU304/CB2679d/Dalcinonacog alfa has been studied in one clinical trial, identified as NCT03186677. This was a dose-escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of the drug in Hemophilia B patients. The trial was conducted in South Korea and has been completed.
Yes, ISU304/CB2679d/Dalcinonacog alfa is also known as Dalcinonacog alfa. These names refer to the same investigational drug being developed by Catalyst Pharmaceuticals for Hemophilia B.