Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of chronic hepatitis C. It is currently in Phase 1 clinical development and has been studied in healthy volunteers and in patients with chronic hepatitis C infection.
HEC110114 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials for this drug candidate in China.
HEC110114 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in patients with chronic hepatitis C. The drug is still investigational and has not been approved by regulatory authorities.
HEC110114 has been studied in two completed Phase 1 clinical trials. The first trial, NCT03903081, evaluated tolerability and pharmacokinetics in 93 healthy adult subjects. The second trial, NCT04202952, assessed tolerability, pharmacokinetics, and pharmacodynamics in 24 subjects with chronic hepatitis C.
HEC110114 is a distinct investigational small molecule developed by Sunshine Biopharma Inc. for chronic hepatitis C. It is not known to be the same as any other marketed hepatitis C medication, and it is currently in early-stage clinical development.