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HEC53856 · 3 trials · 5 indications
To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule
To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule
| Arm | Type | Description |
|---|---|---|
| HEC53856 | EXPERIMENTAL | Drug: HEC53856 TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg |
| Roxadustat | ACTIVE_COMPARATOR | Drug: roxadustat TIW dosing There will be only one cohort: 70mg |
| Placebo | PLACEBO_COMPARATOR | Drug: placebo TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg |
| single ascending | EXPERIMENTAL | Drug or placebo, oral, fast, single dose ascending |
| multiple ascending | EXPERIMENTAL | Drug or placebo, oral, fast, multiple dose ascending |
| Food Effect | EXPERIMENTAL | Drug or placebo, oral, fed or fast, single dose |
| Name | Type | Description |
|---|---|---|
| HEC53856 | DRUG | Either dose of HEC53856 will be administered after fasting . |
| Roxadustat | DRUG | Roxadustat will be administered after fasting . |
| Placebo | DRUG | Either dose of placebo will be administered after fasting . |
Inclusion Criteria: 1. Patients who agree to participate in this clinical trial and sign an informed consent form; 2. Age 18\~65 years old; Weight 40\~90Kg, including critical value; 3. Glomerular filtration rate (eGFR) calculated by CKD-EPI formula 15mL/min/1.73 m\^2 \< or = eGFR \< 60 mL/min/1.73...
HEC53856 is an investigational small molecule being developed for chronic kidney diseases, renal anemia, and hemodialysis. It has been studied in healthy volunteers and in patients with non-dialysis renal anemia and end-stage renal disease receiving dialysis. The drug is in Phase 1 clinical development.
HEC53856 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The drug is currently in Phase 1 clinical trials.
HEC53856 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed in healthy volunteers and in patients with chronic kidney disease and renal anemia.
HEC53856 has been studied in three completed Phase 1 trials. NCT03886688 evaluated single and multiple oral dosing in healthy volunteers. NCT04925661 studied the drug in patients with non-dialysis renal anemia. NCT04925674 examined HEC53856 in patients with end-stage renal disease receiving dialysis.
HEC53856 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.