Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DSP loaded RBC using EryDex System · 1 trial · 1 indication
The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
| Arm | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | ACTIVE_COMPARATOR | Autologous RBC loaded with DSP using the EDS process, and treated RBC are infused to the subject. |
| Sham treated RBC using the EryDex System | SHAM_COMPARATOR | Autologous RBC are treated with buffer using the EDS process, and treated RBC are infused to the subject. |
| Name | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | DRUG | Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
| Sham treated RBC using the EryDex System | DRUG | Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
Inclusion Criteria: * If female of childbearing potential\*, the subject agrees not to donate ova and to use one of 4 methods of contraception from the time of signing the informed consent until 2 months after infusion * If male, the subject agrees to not donate sperm and to use barrier contracepti...
DSP loaded RBC using EryDex System is an investigational small molecule being studied in healthy volunteers. It is a formulation of dexamethasone sodium phosphate (DSP) loaded into red blood cells using the EryDex System. The drug is currently in Phase 1 clinical development.
DSP loaded RBC using EryDex System is being developed by Quince Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker QNCX. The company is conducting clinical trials to evaluate this investigational drug in healthy volunteers.
DSP loaded RBC using EryDex System is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under investigation.
DSP loaded RBC using EryDex System has one completed clinical trial, NCT02380924, titled 'Recovery and Survival of EryDex in Non-patient Volunteers.' This Phase 1 study enrolled 10 healthy participants in the United States and was an active-controlled, randomized trial.
DSP loaded RBC using EryDex System is the drug product being studied, and the clinical trial NCT02380924 refers to 'EryDex' in its title. The trial evaluated the recovery and survival of the EryDex product in healthy volunteers, indicating these names refer to the same investigational therapy.