Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of chronic hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its tolerability and pharmacokinetics.
Kangdaprevir is being developed by Sunshine Biopharma Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy subjects. Sunshine Biopharma's stock is traded under the ticker symbol SBFM.
Kangdaprevir is in Phase 1 clinical development. A Phase 1 clinical trial has been completed, which studied the tolerability and pharmacokinetics of Kangdaprevir sodium tablets in healthy adult subjects. The drug remains investigational and is not yet approved for any use.
Kangdaprevir has one completed clinical trial registered under NCT03811678, titled 'The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.' This Phase 1 study enrolled 120 participants in China and was a randomized, double-blind, controlled trial.
Kangdaprevir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic hepatitis C. The completed Phase 1 trial focused on tolerability and pharmacokinetics in healthy volunteers, and further clinical studies are needed before any regulatory approval could be considered.