PreeclampsiaPhase 1NCT06924385
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
A Phase 1 study testing Telpegfilgrastim Injection in people with Preeclampsia, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant women of childbearing. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Telpegfilgrastim Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2025to 20 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and are fully aware of the possible adverse reactions, and voluntarily sign the informed consent form before the trial.
- Female, aged between 18 and 45 years old (inclusive of 18 and 45 years old).
- Body Mass Index (BMI) ≥18.5 and <28.0 kg/m^2, weight ≥45 kg.
- Healthy, childbearing-age, non-pregnant women: At the screening visit and before the first dose administration, a comprehensive physical examination is conducted, including general physical examination, vital signs (pulse between 50 and 100 bpm at rest, systolic blood pressure between 90 and 139 mmHg, diastolic blood pressure between 50 and 89 mmHg, inclusive of the critical values), as well as laboratory tests [blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urine routine, etc.] and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) showing all parameters normal or abnormal but without clinical significance.
- Willing to participate in the planned PK blood sampling studies and able to comply with the medication and blood sample collection procedures.
- Negative blood pregnancy test within 24 hours before the first dose administration, and the participant must agree to use effective contraceptive measures during the study period and for 6 months after medication. The participant must agree to use at least one of the following contraceptive methods: condom; subcutaneous contraceptive implant; intrauterine device or intrauterine system; high-efficiency oral contraceptives, with or without progestin; injectable progestin; contraceptive vaginal ring; transdermal contraceptive patch.
- Women of childbearing age with a history of preeclampsia: A documented history of pulmonary embolism (PE), requiring confirmation of the diagnosis through prior hospitalization medical records.
Who cannot join
- Healthy, childbearing-age, non-pregnant women: Those with organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions affecting the central nervous system, cardiovascular system, cerebrovascular, hematological system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction.
- Healthy, childbearing-age, non-pregnant women: Those with gastrointestinal, liver, kidney, or other known diseases that interfere with drug absorption, distribution, metabolism, or excretion.
- Suffering from malignant tumors or any history of any malignancy within 5 years prior to screening (except for completely resected carcinoma in situ of the cervix, non-metastatic cutaneous squamous cell carcinoma, or basal cell carcinoma).
- History of organ transplantation or use of immunosuppressants agents within in the past 3 months or planned use, including but not limited to; calcineurin inhibitors such as tacrolimus and cyclosporine; mycophenolate agents such as mycophenolate mofetil and mycophenolate sodium enteric-coated tablets; glucocorticoids medications such as prednisone and methylprednisolone; others such as sirolimus, azathioprine, mizoribine and leflunomide;
- A history of poorly controlled psychiatric disorders with medication.
- Current or history of severe or persistent infection within the past 3 months (requiring hospitalization or opportunistic infections); or evidence of active and uncontrolled viral infections, such as HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), syphilis, or any bacterial, parasitic, or fungal infection requiring treatment.
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- Allergy to rhG-CSF products (including rhG-CSF and PEG-modified rhG-CSF) and their components, or allergy to recombinant human proteins or polypeptide drugs derived from E. coli.
- Use of human granulocyte colony-stimulating factor (G-CSF) therapies within the past 3 months prior to screening; planned or current use of drugs with potential drug interactions with G-CSF therapies, such as lithium;
- Use of any prescription or over-the-counter drugs (including traditional Chinese medicine, health supplements, etc.) within 14 days before the first dose of the test drug or during the drug's 5 half-lives (whichever is longer), unless both the researcher and the sponsor agree that it has no impact on the clinical study.
- Current or planned use of aspirin, statins, and/or any other drugs that affecting the pathogenesis of preeclampsia (including but not limited to low molecular weight heparin, broccoli sprout extract tablets, digoxin immune Fab, recombinant antithrombin III, proton pump inhibitors, metformin, etc.);
- Vaccination with live or attenuated vaccines within 3 months before the start of the trial.
- History of drug abuse, drug use, or alcoholism (drug abuse history or use of narcotics in the past five years; consumption of 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Smoking (or use of tobacco products) in the past 3 months, or those who do not agree to refrain from smoking during the study period.
- Participation in a clinical drug trial within 3 months before screening or 5 times the drug's half-life as specified in other trial drug package inserts/investigator brochures/informed consent forms (whichever is longer), or other conditions deemed unsuitable for enrollment by the researcher.
- Women of childbearing age with a history of preeclampsia: A history/current blood system disease (myelodysplastic syndrome, thalassemia, sickle cell anemia, hemolytic anemia, hemophilia, and/or bleeding disorders).
- Women of childbearing age with a history of preeclampsia: Congestive heart failure (NYHA class II~IV), myocardial infarction, unstable angina, and/or severe heart disease in the past or present within 6 months before enrollment.
- Women of childbearing age with a history of preeclampsia: Severe cerebrovascular disease within 6 months before enrollment.
- Women of childbearing age with a history of preeclampsia: Evaluation by the investigator at the time of screening for significant lung disease.
- Women of childbearing age with a history of preeclampsia: Severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) or uncontrolled hypertension after antihypertensive medication treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg) or malignant hypertension, hypertensive emergency, hypertensive urgency, etc.
- Women of childbearing age with a history of preeclampsia: Severe or malignant retinopathy. Severe lesions are defined as retinal hemorrhage, microaneurysms, cotton-wool spots, hard exudates, or a combination thereof. Malignant lesions are defined as severe retinopathy combined with optic disc edema.
- Women of childbearing age with a history of preeclampsia: Poorly controlled diabetes, poorly controlled thyroid disease with medication.
- Women of childbearing age with a history of preeclampsia: Severe liver disease or liver dysfunction (ALT or AST >2×ULN), renal impairment, creatinine (Cr) >1.5×ULN.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijin, Beijing Municipality, 100191
About this study
Official title: A Phase Ⅰa Clinical Trial Designed to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Properties of Multiple Doses of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant women of childbearing. It contains two cohorts: Cohort 1, healthy childbearing-age non-pregnant participants, and Cohort 2, childbearing-age non-pregnant participants with a history of preeclampsia, totaling 30 non-pregnant women of childbearing age will be enrolled.
Each participant in Cohort 2 will go through a screening period, a baseline phase (the day before the first dose), a treatment period, and a follow-up period after dosing.
- Conditions
- Preeclampsia
- Being tested
- Telpegfilgrastim Injection
- Keywords
- PEG-rhG-CSF, Telpegfilgrastim Injection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telpegfilgrastim InjectionDrug
Telpegfilgrastim will be administered as subcutaneous (SC) injection.
Telpegfilgrastim InjectionDrug
Telpegfilgrastim will be administered as subcutaneous (SC) injection.
Telpegfilgrastim InjectionDrug
Telpegfilgrastim will be administered as subcutaneous (SC) injection.
Telpegfilgrastim InjectionDrug
Telpegfilgrastim will be administered as subcutaneous (SC) injection.
Telpegfilgrastim InjectionDrug
Telpegfilgrastim will be administered as subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:telpegfilgrastim Injection low dose group | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Cohort 1:telpegfilgrastim Injection middle dose group | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Cohort 1:telpegfilgrastim Injection high dose group | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Cohort 2:telpegfilgrastim Injection low dose group | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Cohort 2:telpegfilgrastim Injection high dose group | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event（AE）.
Measured: Week1-6.
respiration.
Measured: Week1-6.
body temperature.
Measured: Week1-6.
Number of participants with clinically significant change from baseline in physical examination.
Measured: Week1-6.
Number of participants with clinically significant change from baseline in laboratory test.
Measured: Week1-6.
Electrocardiogram.
Measured: Week1-6.
Anti-drug antibody.
Measured: week1-6.
Area under the plasma drug concentration-time curve, AUC 0-t.
Measured: Day36.
Area Under the Concentration-Time Curve from time 0 to time tau,AUC 0-tau.
Measured: Day36.
Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞.
Measured: Day36.
Maximum concentration (Cmax)
Measured: Day36.
Time to maximum concentration(Tmax)
Measured: Day36.
Drug half-life (t1/2)
Measured: Day36.
Steady-state peak concentration (Css_max)
Measured: Day36.
Steady-state trough concentration (Css_min)
Measured: Day36.
Steady-state average concentration (Css_avg)
Measured: Day36.
Apparent clearance (CL/F)
Measured: Day36.
Apparent volume of distribution (Vd/F)
Measured: Day36.
Fluctuation index (DF)
Measured: Day36.
Accumulation ratio at steady state (Rss)
Measured: Day36.
Secondary outcomes (8)
VEGF(Vascular Endothelial Growth Factor)
Measured: Day 36
IL-4(Interleukin-4)
Measured: Day 36
IL-6(Interleukin-)
Measured: Day 36
IL-10(Interleukin-10)
Measured: Day 36
TNF-α(Tumor Necrosis Factor-α)
Measured: Day 36
TGF-β(Transforming Growth Factor-β)
Measured: Day 36
Th17/Treg cell ratio
Measured: Day 36
CD34+ cell level
Measured: Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start6 Apr 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor
- Investigators
- Yuan Wei, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924385
- Sponsor's protocol ID
- PG-4-1-003
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰa Clinical Trial Designed to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Properties of Multiple Doses of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
- ClinicalTrials.gov ID
- NCT06924385
- Acronym / sponsor ID
- PG-4-1-003
- Conditions
- Preeclampsia
- Keywords
- PEG-rhG-CSF, Telpegfilgrastim Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Third Hospital
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant women of childbearing. It contains two cohorts: Cohort 1, healthy childbearing-age non-pregnant participants, and Cohort 2, childbearing-age non-pregnant participants with a history of preeclampsia, totaling 30 non-pregnant women of childbearing age will be enrolled.
Each participant in Cohort 2 will go through a screening period, a baseline phase (the day before the first dose), a treatment period, and a follow-up period after dosing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:telpegfilgrastim Injection low dose group | Experimental | Drug: Telpegfilgrastim Injection |
| Cohort 1:telpegfilgrastim Injection middle dose group | Experimental | Drug: Telpegfilgrastim Injection |
| Cohort 1:telpegfilgrastim Injection high dose group | Experimental | Drug: Telpegfilgrastim Injection |
| Cohort 2:telpegfilgrastim Injection low dose group | Experimental | Drug: Telpegfilgrastim Injection |
| Cohort 2:telpegfilgrastim Injection high dose group | Experimental | Drug: Telpegfilgrastim Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants are able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and are fully aware of the possible adverse reactions, and voluntarily sign the informed consent form before the trial.
- Female, aged between 18 and 45 years old (inclusive of 18 and 45 years old).
- Body Mass Index (BMI) ≥18.5 and <28.0 kg/m^2, weight ≥45 kg.
- Healthy, childbearing-age, non-pregnant women: At the screening visit and before the first dose administration, a comprehensive physical examination is conducted, including general physical examination, vital signs (pulse between 50 and 100 bpm at rest, systolic blood pressure between 90 and 139 mmHg, diastolic blood pressure between 50 and 89 mmHg, inclusive of the critical values), as well as laboratory tests [blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urine routine, etc.] and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) showing all parameters normal or abnormal but without clinical significance.
- Willing to participate in the planned PK blood sampling studies and able to comply with the medication and blood sample collection procedures.
Key exclusion criteria (22 listed)
- Healthy, childbearing-age, non-pregnant women: Those with organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions affecting the central nervous system, cardiovascular system, cerebrovascular, hematological system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction.
- Healthy, childbearing-age, non-pregnant women: Those with gastrointestinal, liver, kidney, or other known diseases that interfere with drug absorption, distribution, metabolism, or excretion.
- Suffering from malignant tumors or any history of any malignancy within 5 years prior to screening (except for completely resected carcinoma in situ of the cervix, non-metastatic cutaneous squamous cell carcinoma, or basal cell carcinoma).
- History of organ transplantation or use of immunosuppressants agents within in the past 3 months or planned use, including but not limited to; calcineurin inhibitors such as tacrolimus and cyclosporine; mycophenolate agents such as mycophenolate mofetil and mycophenolate sodium enteric-coated tablets; glucocorticoids medications such as prednisone and methylprednisolone; others such as sirolimus, azathioprine, mizoribine and leflunomide;
- A history of poorly controlled psychiatric disorders with medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telpegfilgrastim InjectionTelpegfilgrastim will be administered as subcutaneous (SC) injection. | Drug | Cohort 1:telpegfilgrastim Injection low dose group |
| Telpegfilgrastim InjectionTelpegfilgrastim will be administered as subcutaneous (SC) injection. | Drug | Cohort 1:telpegfilgrastim Injection middle dose group |
| Telpegfilgrastim InjectionTelpegfilgrastim will be administered as subcutaneous (SC) injection. | Drug | Cohort 1:telpegfilgrastim Injection high dose group |
| Telpegfilgrastim InjectionTelpegfilgrastim will be administered as subcutaneous (SC) injection. | Drug | Cohort 2:telpegfilgrastim Injection low dose group |
| Telpegfilgrastim InjectionTelpegfilgrastim will be administered as subcutaneous (SC) injection. | Drug | Cohort 2:telpegfilgrastim Injection high dose group |
Primary outcome
Adverse Event（AE）.
Time frame: Week1-6.
respiration.
Time frame: Week1-6.
body temperature.
Time frame: Week1-6.
Number of participants with clinically significant change from baseline in physical examination.
Time frame: Week1-6.
Number of participants with clinically significant change from baseline in laboratory test.
Time frame: Week1-6.
Electrocardiogram.
Time frame: Week1-6.
Anti-drug antibody.
Time frame: week1-6.
Area under the plasma drug concentration-time curve, AUC 0-t.
Time frame: Day36.
Area Under the Concentration-Time Curve from time 0 to time tau,AUC 0-tau.
Time frame: Day36.
Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞.
Time frame: Day36.
Maximum concentration (Cmax)
Time frame: Day36.
Time to maximum concentration(Tmax)
Time frame: Day36.
Drug half-life (t1/2)
Time frame: Day36.
Steady-state peak concentration (Css_max)
Time frame: Day36.
Steady-state trough concentration (Css_min)
Time frame: Day36.
Steady-state average concentration (Css_avg)
Time frame: Day36.
Apparent clearance (CL/F)
Time frame: Day36.
Apparent volume of distribution (Vd/F)
Time frame: Day36.
Fluctuation index (DF)
Time frame: Day36.
Accumulation ratio at steady state (Rss)
Time frame: Day36.
8 secondary outcomes
VEGF(Vascular Endothelial Growth Factor)
Time frame: Day 36
IL-4(Interleukin-4)
Time frame: Day 36
IL-6(Interleukin-)
Time frame: Day 36
IL-10(Interleukin-10)
Time frame: Day 36
TNF-α(Tumor Necrosis Factor-α)
Time frame: Day 36
TGF-β(Transforming Growth Factor-β)
Time frame: Day 36
Th17/Treg cell ratio
Time frame: Day 36
CD34+ cell level
Time frame: Day 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Wei, Ph.D principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telpegfilgrastim Injection in people with Preeclampsia, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event（AE）. (time frame: Week1-6.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.