Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
eASC · 1 trial · 1 indication
* Pain in administration area will be assessed by a visual analogical scale. * Medical exploration of the administration area will be performed to identify any skin reaction. * Inguinal scan will be performed to assess any lymphatic node modification. * Systemic tolerability will be measured by number of AE (Adverse Event) recorded at any time, including any alteration in laboratory parameters and/or physical exploration.
| Arm | Type | Description |
|---|---|---|
| eASC | EXPERIMENTAL | eASC * First cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 2.5 millions of eASCs suspended in 0.25 ml of HTS per lymph node, total dose 5 millions of cells. * Second cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 5 millions of eASCs suspended in 0.5 ml of HTS per lymph node, total dose 10 millions of cells. |
| Placebo | PLACEBO_COMPARATOR | * First cohort (2 volunteers): injection of 0.25 ml of Hypo Thermosol (HTS) per lymph node * Second cohort (2 volunteers): injection of 0.5 ml of Hypo Thermosol (HTS) per lymph node |
| Name | Type | Description |
|---|---|---|
| eASC | GENETIC | * First cohort: Intra lymph node injection of 2.5 millions of eASCs suspended in 0.5 ml of HypoThermosol per lymph node, total dose 5 millions of cells. * Second cohort: Intra lymph node injection of 5 millions of eASCs suspended in 0.25 ml of HypoThermosol per lymph node, total dose 10 millions of cells. |
| Placebo | DRUG | * First cohort (2 volunteers): injection of 0.25 ml of HypoThermosol (HTS) per lymph node * Second cohort (2 volunteers): injection of 0.5 ml of HypoThermosol (HTS) per lymph node |
Inclusion Criteria: * Age between 18 and 55 both included * Inform Consent Form signed * Body Mass Index (BMI) between 19 and 29 kg/m2 * Presence of, at least, one lymph node of 1cm in its larger diameter in each inguinal location. It has to be accessible for administration after its localization u...
eASC is an investigational gene therapy being studied for the treatment of localized adverse reactions to drug administration. It is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.
eASC is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker TAK. The company is conducting clinical research on this gene therapy candidate.
eASC is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
eASC has one completed clinical trial, NCT01743222, titled "Intralymphatic eASC Administration in Healthy Volunteers." This Phase 1 study enrolled 10 participants in Spain and was placebo-controlled, though it was not double-blinded.
Yes, eASC is classified as a gene therapy. It is being investigated for its potential to address localized adverse reactions to drug administration, and its clinical trial included biomarker selection for participants.