Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
Summary
This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant women. It plans to enroll 18 healthy premenopausal non-pregnant female.,). Participants will be enrolled sequentially according to their screening numbers in the following three dose groups:0.25mg, 0.5mg, and 1mg, with 6 participants in each dose group. Each participant will undergo a screening period (-2 weeks to -2 days), a baseline phase (D-1, the day before the first dose), and a post-dosing observation period (Day 1 to Day 21), and adverse event, vital signs, physical examination, laboratory tests,and PK\&PD will be calculated.
Timeline
- Start
- 2025-03-26
- Primary completion
- 2025-05-08
- Completion
- 2025-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telpegfilgrastim | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Subject | Telpegfilgrastim | Protein / enzyme biologic | 0.5 mg | Subcutaneous |
| Subject | Telpegfilgrastim | Protein / enzyme biologic | 1 mg | Subcutaneous |