drugset / Trial / NCT03206229
Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects
RandomizedCrossoverDouble-blindTreatment
Summary
This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT). All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.
Timeline
- Start
- 2017-02-13
- Primary completion
- 2017-06-02
- Completion
- 2018-01-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 2 mg | Subcutaneous |
Indications
No indication recorded.