Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Kangdaprevir Sodium Tablet
Kangdaprevir · 1 trial · 1 indication
To assess the tolerability after a single and multiple dose of HEC84048
Maximum observed plasma concentration of HEC84048
Time of the maximum observed plasma concentration of HEC84048
Area under the plasma concentration-time curve (AUC)
Terminal elimination half-life
Apparent volume of distribution
Oral clearance
Mean Residence Time
| Arm | Type | Description |
|---|---|---|
| 50 mg single dose | EXPERIMENTAL | It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). |
| 100 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. |
| 200 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). |
| 400 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). |
| 600 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). |
| 800 mg single dose | EXPERIMENTAL | Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). |
| 100 mg multiple dose | EXPERIMENTAL | Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. |
| 200 mg multiple dose | EXPERIMENTAL | Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. |
| 400 mg multiple dose | EXPERIMENTAL | Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. |
| Name | Type | Description |
|---|---|---|
| Kangdaprevir Sodium Tablet | DRUG | Tablet，administered orally once daily |
| placebo | DRUG | Tablet，administered orally once daily |
Inclusion Criteria: * Able to comprehend and sign the ICF voluntarily prior to initiate the study; * Able to complete the study according to the protocol; * Between 18 and 45 years of age（18 and 45 are inclusive）; * Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Bo...
Kangdaprevir is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM) for the treatment of chronic hepatitis C, an infectious disease. It is being studied as a Phase 1 clinical candidate and has not been approved by the FDA. It is also known as Kangdaprevir Sodium Tablet.
Kangdaprevir is being developed for the treatment of chronic hepatitis C, a viral infection of the liver. Development is at the Phase 1 stage, so the drug remains investigational and is not approved for prescribing. Its only completed trial enrolled healthy adult volunteers rather than patients with chronic hepatitis C.
Kangdaprevir is developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the Kangdaprevir Sodium Tablet program, which targets chronic hepatitis C. Development is currently at the Phase 1 stage.
Kangdaprevir is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it is still in clinical development, Kangdaprevir is investigational and has not been approved by the FDA for any indication, including chronic hepatitis C.
Kangdaprevir has been studied in one completed Phase 1 trial, NCT03811678, titled The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects. The trial enrolled 120 healthy adult volunteers in China, was randomized, double blind, and controlled, and included participants aged 18 years and older of all sexes.
Yes, Kangdaprevir Sodium Tablet is an alternative name for Kangdaprevir. Both names refer to the same investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM) for chronic hepatitis C. The completed Phase 1 trial, NCT03811678, used the Kangdaprevir Sodium Tablet formulation.