Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hercules · 1 trial · 1 indication
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized Cmax based on the equivalence criterion that Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-last based on the equivalence criterion that AUC0-last least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-∞, based on the equivalence criterion that AUC0-∞ least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Hercules: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment B | ACTIVE_COMPARATOR | Herceptin EU: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment C | ACTIVE_COMPARATOR | Herceptin US: 8 mg/kg i.v. infusion over 90 minutes |
| Name | Type | Description |
|---|---|---|
| Hercules | BIOLOGICAL | Powder Concentrate for Intravenous Infusion, 150 mg/vial |
| Herceptin EU | BIOLOGICAL | Powder for Concentrate for Solution for Infusion, 150 mg/vial |
| Herceptin US | BIOLOGICAL | Intravenous Infusion, 440 mg/vial |
Inclusion Criteria: * healthy adult subjects, age 18 to 55 years old * able to understand procedures, agree to participate and willing to give informed consent Exclusion Criteria: * history of any significant disease * use of any medication 7 days prior to start of study * participation in a clin...
Hercules is an investigational monoclonal antibody being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its therapeutic area is classified as Other.
Hercules is being studied for use in healthy individuals as part of a Phase 1 clinical trial. The trial is designed to evaluate the drug when administered as a single intravenous infusion. The specific condition being investigated is listed as Healthy.
Hercules is being developed by Viatris Inc., a company traded on the stock exchange under the ticker symbol VTRS. Viatris is the developer of this investigational monoclonal antibody, which is currently in Phase 1 clinical trials.
Hercules is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials. The Phase 1 study has been completed.
Hercules has one completed clinical trial registered under NCT02594761, titled "Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion." This Phase 1 trial enrolled 132 healthy male participants aged 18 years and older. The trial was randomized, double-blind, and active-controlled.
Hercules is being studied in a clinical trial that involves trastuzumab, as indicated by the trial title. The trial is specifically evaluating trastuzumab administered as a single intravenous infusion. However, the relationship between the drug name Hercules and trastuzumab is not further specified.