Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegfilgrastim Hospira · 1 trial · 1 indication
AUC0-t will be used as a primary parameter only if AUC0-∞ cannot be calculated for all subjects in the pharmacokinetic population.
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | - |
| Treatment Group 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pegfilgrastim Hospira | DRUG | Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events. |
| Neulasta (Amgen) | DRUG | Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events. |
Inclusion Criteria: * Healthy male or female subjects, 18-55 years inclusive. * Written informed consent given * Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study. * Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive and wei...
Pegfilgrastim Hospira is an investigational pegfilgrastim product developed by Pfizer, Inc. (ticker: PFE). It is a small molecule that acts as an agonist at CSF3R. The drug has been studied in a Phase 1 clinical trial in healthy volunteers.
Pegfilgrastim Hospira targets CSF3R, the colony stimulating factor 3 receptor. It acts as an agonist at this receptor. This target engagement is the basis for its pharmacological activity.
Pegfilgrastim Hospira is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this investigational product.
Pegfilgrastim Hospira is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program includes one completed trial.
Pegfilgrastim Hospira has been evaluated in a single Phase 1 trial, NCT00938678, titled a pharmacokinetic and pharmacodynamic study comparing Pegfilgrastim Hospira to Neulasta in healthy volunteers. The trial enrolled 71 participants, was randomized and active-controlled, and has been completed.