Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HEC74647PA Capsule
HEC74647PA · 3 trials · 2 indications
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
Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647
Change from baseline in HCV RNA following dose administration of HEC74647
Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
Maximum observed plasma concentration of HEC74647
Time of the maximum observed plasma concentration
Area under the plasma concentration-time curve (AUC)
Terminal elimination half-life
To assess the tolerability after a single dose of HEC74647PA capsule
To assess the tolerability after multiple doses of HEC74647PA capsule
Apparent volume of distribution
Oral clearance
Mean Residence Time
| 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 |
| Cohort 1 | EXPERIMENTAL | up to HEC74647PA capsule 50 mg once daily for 3 days |
| Cohort 2 | EXPERIMENTAL | up to HEC74647PA capsule 100 mg once daily for 3 days |
| Cohort 3 | EXPERIMENTAL | up to HEC74647PA capsule 200 mg once daily for 3 days |
| Cohort 4 | PLACEBO_COMPARATOR | up to placebo once daily for 3 days |
| 50 mg single dose | EXPERIMENTAL | It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2). |
| 100 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2). |
| 200 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. |
| 400 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2). |
| 600 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2). |
| 800 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2). |
| 100 mg multiple doses | EXPERIMENTAL | Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. |
| 200 mg multiple doses | EXPERIMENTAL | Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. |
| 400 mg multiple doses | EXPERIMENTAL | Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days. |
| Name | Type | Description |
|---|---|---|
| HEC74647PA+HEC110114 | DRUG | administered orally once daily for 12 weeks |
| Placebo | DRUG | administered orally once daily for 12 weeks |
| HEC74647PA capsule | DRUG | Capsule administered orally once daily |
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 is being studied in adults with chronic HCV infection, including chronic hepatitis C, as part of combination antiviral regimens.
HEC74647PA is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is advancing the asset through clinical development for chronic hepatitis C infection.
HEC74647PA is in Phase 2 clinical development. A Phase 2 trial in adults with chronic hepatitis C has been completed, and earlier Phase 1 studies have also been completed. It is an investigational drug and has not been approved by the FDA.
HEC74647PA has been studied in completed trials including NCT05395416, a Phase 2 trial in chronic HCV infection with 514 participants in China, and NCT04201275, a Phase 1 tolerability, pharmacokinetics and pharmacodynamics study in HCV-infected subjects. A Phase 1 study in healthy volunteers, NCT03673696, has also been completed.