Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC74647PA+HEC110114 · 1 trial · 1 indication
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| HEC74647PA+HEC110114 100 mg/200 mg | EXPERIMENTAL | Phase II: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg or200 mg once daily and HEC110114 tablets 600 mg once daily |
| HEC74647PA+HEC110114 | EXPERIMENTAL | Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg /200 mg once daily and HEC110114 tablets 600 mg once daily |
| Placebo | PLACEBO_COMPARATOR | Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily |
| Name | Type | Description |
|---|---|---|
| HEC74647PA+HEC110114 | DRUG | administered orally once daily for 12 weeks |
| Placebo | DRUG | administered orally once daily for 12 weeks |
Inclusion Criteria: 1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg; 4. Serological detection of anti-HCV antibodies was positive at screening; 5. HCV RNA≥1×104 IU/mL at Screening; 6. HCV genoty...
HEC74647PA is an investigational small molecule being developed for the treatment of chronic hepatitis C virus (HCV) infection. It has been studied in healthy subjects and in patients with chronic HCV infection, including in combination with other antiviral agents.
HEC74647PA is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company has conducted clinical trials of the drug in China.
HEC74647PA is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including studies in healthy subjects and in patients with chronic hepatitis C. The drug remains investigational and has not been approved by regulatory authorities.
HEC74647PA has been studied in several completed clinical trials, including NCT03673696, a Phase 1 tolerability and pharmacokinetics study in healthy adults; NCT04201275, a Phase 1 study in HCV-infected subjects; and NCT05504876, a drug interaction study with midazolam. A Phase 2 trial, NCT05395416, evaluated the drug in combination with Yiqibuvir tablets in patients with chronic HCV infection.
HEC74647PA is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available clinical trial information, so the exact mechanism of action is not described here.
HEC74647PA is also known as Antaitavir Hasophate, as referenced in the Phase 2 clinical trial NCT05395416, which studied Antaitavir Hasophate Capsules combined with Yiqibuvir Tablets in patients with chronic hepatitis C. This alternative name may be used interchangeably in clinical research.