Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC74647PA · 3 trials · 2 indications
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 |
|---|---|---|
| Midazolam Syrup HEC74647PA HEC110114 | EXPERIMENTAL | Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3\~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9. |
| 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 |
|---|---|---|
| Midazolam Syrup | DRUG | Administered Midazolam Syrup 5 mg orally once daily in fed state; |
| HEC74647PA | DRUG | Administered HEC74647PA 100 mg orally once daily in fed state; |
| HEC110114 | DRUG | Administered HEC110114 600 mg orally once daily in fed state; |
| HEC74647PA capsule | DRUG | Capsule administered orally once daily |
| placebo | DRUG | HEC74647PA capsule matching placebo administered orally once daily |
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 3 months a...
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.