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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 fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a more severe form of fatty liver disease. It is currently in Phase 2 clinical development for non-cirrhotic NASH.
HEC96719 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical trials of the drug in patients with non-alcoholic steatohepatitis.
HEC96719 is in Phase 2 clinical development. The drug has completed Phase 1 trials in healthy volunteers and a Phase 2 trial in patients with non-cirrhotic non-alcoholic steatohepatitis. It is not yet approved by regulatory authorities and remains investigational.
HEC96719 has been studied in four completed clinical trials. These include Phase 1 trials in healthy volunteers in China and Australia (NCT04194242, NCT04422496, NCT04546984) and a Phase 2 trial in patients with non-cirrhotic NASH in China (NCT05397379).
HEC96719 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for non-alcoholic steatohepatitis. The drug has completed several clinical trials but has not yet received regulatory approval for any indication.
HEC96719 is a small molecule being developed for the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The specific molecular target of the drug has not been disclosed in the available clinical trial information.