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Also known as HEC110114 tablet
HEC110114 · 2 trials · 1 indication
Incidence of adverse events
| Arm | Type | Description |
|---|---|---|
| 600 mg multiple doses | EXPERIMENTAL | Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
| 800 mg multiple doses | EXPERIMENTAL | Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
| 1200 mg multiple doses | EXPERIMENTAL | Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days |
| 100 mg single dose | EXPERIMENTAL | It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 300 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 600 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 800 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study |
| 1000 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 1200 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 1600 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| 1000 mg multiple doses | EXPERIMENTAL | Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
| Name | Type | Description |
|---|---|---|
| HEC110114 Tablet | DRUG | administered orally once daily |
| Sofosbuvir Tablet | DRUG | administered orally once daily |
| Placebo Oral Tablet | DRUG | Placebo will be administered orally at a dose and frequency matched to HEC110114 |
Inclusion Criteria: * Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; * Be able to complete the study according to the trail protocol; * Subjects (including partners) have no pregnancy plan within six months...
HEC110114 is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM) for the treatment of chronic hepatitis C, an infectious disease of the liver. It is administered as a tablet and is currently in Phase 1 clinical development. It has not been approved for any use.
HEC110114 is being developed for the treatment of chronic hepatitis C. Both of its completed Phase 1 trials enrolled subjects under the chronic hepatitis C condition, one in HCV-infected patients and one in healthy adult volunteers. It remains investigational and is not approved for the treatment of hepatitis C or any other condition.
HEC110114 is developed by Sunshine Biopharma Inc., which trades on the Nasdaq under the ticker symbol SBFM. The company is the sponsor of the clinical program for this small molecule hepatitis C candidate.
HEC110114 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The program has enrolled 117 subjects in total across those two completed studies. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
Two completed Phase 1 trials have evaluated HEC110114. NCT03903081 studied tolerability and pharmacokinetics in 93 healthy adult subjects. NCT04202952 studied tolerability, pharmacokinetics and pharmacodynamics in 24 HCV-infected subjects. Both trials were conducted in China, were randomized, double-blind and controlled, and enrolled adults aged 18 years and older.
Yes. HEC110114 tablet and HEC110114 Tablet are alternative names for the same investigational drug, HEC110114, developed by Sunshine Biopharma Inc. for chronic hepatitis C. The tablet is the oral dosage form used in the Phase 1 clinical trials of the compound.