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HEC53856 · 2 trials · 4 indications
To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after 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 |
| 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 by Sunshine Biopharma Inc. (ticker SBFM) for hematology indications. It is in Phase 1 clinical development for chronic kidney disease and hemodialysis, specifically for patients with renal anemia. It has been studied in two completed Phase 1 trials in China.
HEC53856 is being developed for the treatment of renal anemia in patients with chronic kidney disease, including those on hemodialysis or peritoneal dialysis. It is intended for non-dialysis renal anemia as well. The drug remains investigational and has not been approved for any indication.
HEC53856 is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is advancing the small molecule through Phase 1 clinical development for chronic kidney disease and hemodialysis-related anemia.
HEC53856 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in patients with end-stage renal disease receiving dialysis and one in patients with non-dialysis renal anemia. No later-phase trials are currently active.
HEC53856 has been evaluated in two completed Phase 1 trials. NCT04925674 studied the drug in patients with end-stage renal disease receiving dialysis, enrolling 60 participants in China. NCT04925661 studied it in patients with non-dialysis renal anemia, enrolling 40 participants in China. Both trials were randomized, double-blind, and placebo-controlled.