PreeclampsiaPhase 1NCT06893796
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
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, 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.,). 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
- 26 Mar 2025to 8 May 2025
- 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
- The participants is able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and is fully aware of the possible adverse reactions, voluntarily signing the informed consent form before enrolling the trial.
- Female, aged between 18 and 45 years old (inclusive of 18 and 45 years).
- Body Mass Index (BMI) ≥ 18.5 and < 28.0 kg/m², weight ≥ 45 kg.
- At the screening visit and before the first dose on Day 1, 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), laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urinalysis, etc.), and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) with all indices normal or abnormal but without clinical significance.
- Willing to participate in the planned pharmacokinetic (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, and the participant must agree to use effective contraceptive measures during the study period and for 6 months after medication, agreeing to use at least one of the following contraceptive methods:
- 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.
Who cannot join
- Significant prolongation of QT/QTc interval during the screening period and baseline (e.g., repeatedly confirmed QTcF interval > 450 ms);
- Organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions in the central nervous system, cardiovascular system, cerebrovascular, hematologic, urinary, digestive, respiratory, metabolic, and musculoskeletal systems; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction;
- Diseases of the gastrointestinal tract, liver, kidneys, or other conditions known to 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);
- Other risk factors for torsades de pointes ventricular tachycardia (TdP) in the medical history (such as heart failure, hypokalemia, family history of long QT syndrome);
- 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;
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- History of poorly controlled psychiatric illness with medication;
- Current or history of severe or persistent infection within the past 3 months (requiring hospitalization or opportunistic infection); 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;
- 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 Escherichia 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 medications (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 investigator 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.);
- Concomitant use with drugs that prolong the QT/QTc interval;
- 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-containing products) in the past 3 months, or unwillingness to refrain from smoking during the study period;
- Participation in a clinical drug trial within the past 3 months or during the time frame equivalent to 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 inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Phase Ia Clinical Trial Aimed at Evaluating the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of Single Dose of Telpegfilgrastim Injection in Healthy Premenopausal Non-pregnant Women
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.
- 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 Injection,0.25mg, s.c.,day 1 single dose .
Telpegfilgrastim InjectionDrug
Telpegfilgrastim Injection,0.5mg, s.c.,day 1 single dose .
Telpegfilgrastim InjectionDrug
Telpegfilgrastim Injection,1mg, s.c.,day 1 single dose .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Group 2 | Experimental | Not described Receives: Drug: Telpegfilgrastim Injection |
| Group 3 | 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: Day1-21.
blood pressure
Measured: Day1-21.
pulse
Measured: Day1-21.
respiration
Measured: Day1-21.
Temperature
Measured: Day1-21.
Number of participants with clinically significant change from baseline in physical examination.
Measured: Day1-21.
Number of participants with clinically significant change from baseline in laboratory test.
Measured: Day1-21.
Number of participants with clinically significant change from baseline in ultrasound imaging.
Measured: Day1-21.
Electrocardiogram (including QT/QTc interval)
Measured: Day1-21
Anti-drug antibody.
Measured: Day1-21
Area under the plasma drug concentration-time curve, AUC 0-t.
Measured: Day15,336 hours after dosing.
Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞.
Measured: Day15，336 hours after dosing.
Maximum concentration (Cmax)
Measured: Day15，336 hours after dosing.
Time to maximum concentration(Tmax)
Measured: Day15，336 hours after dosing.
Drug half-life (t1/2)
Measured: Day15，336 hours after dosing.
Clearance (CL/F)
Measured: Day15，336 hours after dosing.
Apparent Volume of Distribution (Vd/F)
Measured: Day15，336 hours after dosing.
Secondary outcomes (1)
CD34+ cell level
Measured: Day21，21 days after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start26 Mar 2025
- Primary completion8 May 2025
- Study completion8 May 2025
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
- Dongyang Liu, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893796
- Sponsor's protocol ID
- PG-4-1-002
- Status last verified
- May 2025
- First submitted
- 6 Mar 2025
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial Aimed at Evaluating the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of Single Dose of Telpegfilgrastim Injection in Healthy Premenopausal Non-pregnant Women
- ClinicalTrials.gov ID
- NCT06893796
- Acronym / sponsor ID
- PG-4-1-002
- 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
- 26 Mar 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 25 Mar 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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Telpegfilgrastim Injection |
| Group 2 | Experimental | Drug: Telpegfilgrastim Injection |
| Group 3 | 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)
- The participants is able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and is fully aware of the possible adverse reactions, voluntarily signing the informed consent form before enrolling the trial.
- Female, aged between 18 and 45 years old (inclusive of 18 and 45 years).
- Body Mass Index (BMI) ≥ 18.5 and < 28.0 kg/m², weight ≥ 45 kg.
- At the screening visit and before the first dose on Day 1, 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), laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urinalysis, etc.), and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) with all indices normal or abnormal but without clinical significance.
- Willing to participate in the planned pharmacokinetic (PK) blood sampling studies and able to comply with the medication and blood sample collection procedures.
Key exclusion criteria (17 listed)
- Significant prolongation of QT/QTc interval during the screening period and baseline (e.g., repeatedly confirmed QTcF interval > 450 ms);
- Organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions in the central nervous system, cardiovascular system, cerebrovascular, hematologic, urinary, digestive, respiratory, metabolic, and musculoskeletal systems; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction;
- Diseases of the gastrointestinal tract, liver, kidneys, or other conditions known to 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);
- Other risk factors for torsades de pointes ventricular tachycardia (TdP) in the medical history (such as heart failure, hypokalemia, family history of long QT syndrome);
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 Injection,0.25mg, s.c.,day 1 single dose . | Drug | Group 1 |
| Telpegfilgrastim InjectionTelpegfilgrastim Injection,0.5mg, s.c.,day 1 single dose . | Drug | Group 2 |
| Telpegfilgrastim InjectionTelpegfilgrastim Injection,1mg, s.c.,day 1 single dose . | Drug | Group 3 |
Primary outcome
Adverse Event（AE）
Time frame: Day1-21.
blood pressure
Time frame: Day1-21.
pulse
Time frame: Day1-21.
respiration
Time frame: Day1-21.
Temperature
Time frame: Day1-21.
Number of participants with clinically significant change from baseline in physical examination.
Time frame: Day1-21.
Number of participants with clinically significant change from baseline in laboratory test.
Time frame: Day1-21.
Number of participants with clinically significant change from baseline in ultrasound imaging.
Time frame: Day1-21.
Electrocardiogram (including QT/QTc interval)
Time frame: Day1-21
Anti-drug antibody.
Time frame: Day1-21
Area under the plasma drug concentration-time curve, AUC 0-t.
Time frame: Day15,336 hours after dosing.
Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞.
Time frame: Day15，336 hours after dosing.
Maximum concentration (Cmax)
Time frame: Day15，336 hours after dosing.
Time to maximum concentration(Tmax)
Time frame: Day15，336 hours after dosing.
Drug half-life (t1/2)
Time frame: Day15，336 hours after dosing.
Clearance (CL/F)
Time frame: Day15，336 hours after dosing.
Apparent Volume of Distribution (Vd/F)
Time frame: Day15，336 hours after dosing.
1 secondary outcome
CD34+ cell level
Time frame: Day21，21 days after dosing.
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 30 May 2025.
- 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.
Dongyang Liu, 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 17 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 30 May 2025. 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: Day1-21.). The study lists 17 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 30 May 2025.