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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telpegfilgrastim Injection | Drug | Telpegfilgrastim Injection,0.25mg, s.c.,day 1 single dose . |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) | Day1-21. | |
| blood pressure | Day1-21. | |
| pulse | Day1-21. | |
| respiration | Day1-21. | |
| Temperature | Day1-21. | |
| Number of participants with clinically significant change from baseline in physical examination. | Day1-21. | |
| Number of participants with clinically significant change from baseline in laboratory test. | Day1-21. | |
| Number of participants with clinically significant change from baseline in ultrasound imaging. | Day1-21. | |
| Electrocardiogram (including QT/QTc interval) | Day1-21 | |
| Anti-drug antibody. | Day1-21 | |
| Area under the plasma drug concentration-time curve, AUC 0-t. | Day15,336 hours after dosing. | |
| Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞. |
| Measure | Description | Time Frame |
|---|---|---|
| CD34+ cell level | Day21,21 days after dosing. |
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Inclusion Criteria:
Condoms; Subcutaneous contraceptive implant; Intrauterine device or intrauterine system; High-efficiency oral contraceptives, combined or progestin-only; Injectable progestin; Contraceptive vaginal ring; Transdermal contraceptive patch.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongyang Liu, Ph.D | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Telpegfilgrastim Injection |
| Drug |
Telpegfilgrastim Injection,0.5mg, s.c.,day 1 single dose . |
|
| Telpegfilgrastim Injection | Drug | Telpegfilgrastim Injection,1mg, s.c.,day 1 single dose . |
|
| Day15,336 hours after dosing. |
| Maximum concentration (Cmax) | Day15,336 hours after dosing. |
| Time to maximum concentration(Tmax) | Day15,336 hours after dosing. |
| Drug half-life (t1/2) | Day15,336 hours after dosing. |
| Clearance (CL/F) | Day15,336 hours after dosing. |
| Apparent Volume of Distribution (Vd/F) | Day15,336 hours after dosing. |