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Also known as HEC96719 tablets
HEC96719 · 4 trials · 3 indications
To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD
To assess the safety and tolerability of therapy.
To assess the safe and tolerability of the single ascending-dose
| Arm | Type | Description |
|---|---|---|
| HEC96719 0.25 mg | EXPERIMENTAL | Oral dose once daily for 12 weeks |
| HEC96719 0.35 mg | EXPERIMENTAL | Oral dose once daily for 12 weeks |
| HEC96719 0.5 mg | EXPERIMENTAL | Oral dose once daily for 12 weeks |
| HEC96719 0.25 mg bid | EXPERIMENTAL | Oral dose twice daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Oral dose once or twice daily for 12 weeks |
| Single dose of HEC96719 （Part 1，Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Mulltiple doses HEC96719（ Part 2, Cohort 1） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 2） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 3） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 4） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 5） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| HEC96719 tablets | EXPERIMENTAL | part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B: There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg |
| placebo tablets | PLACEBO_COMPARATOR | part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B:There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg |
| Name | Type | Description |
|---|---|---|
| HEC96719 | DRUG | Oral tablets |
| Placebo | DRUG | Comparator |
| HEC96719 tablets | DRUG | 0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1 |
| Placebo tablet | DRUG | 0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1 |
Inclusion Criteria: * An informed consent document must be signed and dated by the subject * Male or female, 18 to 65 years of age * Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg; * Presumed NASH based on clinical characteristics or prior liver biopsy * MRI PDFF liver fat content ≥ 10...
HEC96719 is an investigational small molecule being developed for non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). It is in Phase 2 clinical development and is not approved for any indication. The program targets the metabolic therapeutic area, specifically liver disease associated with fat accumulation and inflammation.
HEC96719 is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the clinical program evaluating the drug in patients with non-alcoholic steatohepatitis and related fatty liver conditions.
HEC96719 is in Phase 2 clinical development. The Phase 2 study in non-cirrhotic non-alcoholic steatohepatitis has been completed, and earlier Phase 1 studies have also been completed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
HEC96719 has been studied in completed trials including NCT05397379, a Phase 2 safety, tolerability, efficacy, and pharmacokinetics study in non-cirrhotic NASH conducted in China with 68 participants. Earlier Phase 1 trials include NCT04546984, NCT04422496, and NCT04194242, which evaluated safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects in healthy adult subjects.
Yes, HEC96719 tablets is an alternative name for HEC96719. The tablet formulation is the dosage form used in the clinical studies, including the Phase 1 trials conducted in Australia and China and the Phase 2 trial in non-cirrhotic NASH. Both names refer to the same investigational small molecule developed by Sunshine Biopharma.
Across the completed clinical trials, 130 participants have been enrolled in studies of HEC96719. The Phase 2 trial in non-cirrhotic NASH enrolled 68 patients, while the Phase 1 studies enrolled 66, 73, and 64 healthy adult subjects respectively. The Phase 2 study was randomized, double-blind, and placebo-controlled.