BioequivalencePhase 1NCT07096869
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
A Phase 1 study testing Paclitaxel protein-bound particles for injectable suspension (albumin-bound) and Abraxane® in people with Bioequivalence, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound) and Abraxane®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2025to 25 Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as subjects, and sign informed consent prior to the commencement of any study procedure;
- 2) Male and female, ages 18-75 years both inclusive;
- 3) Subjects with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; ②This treatment criteria (NCCN guidelines and CSCO guidelines - Breast cancer) is used to determine whether the subjects are suitable for paclitaxel for injection (albumin-bound) monotherapy. ③Subjects received standard treatment without conditions and were judged to benefit from injectable paclitaxel (albumin-binding) monotherapy;
- 4) ECOG Score ≤ 2 points;
- 5) The expecting life span ≥ 3months;
- 6) The results of blood, liver and kidney function tests are within the following ranges: Absolute neutrophil counts (ANC) ≥ 1.5×10^9/L Platelets (PLT) ≥ 100×10^9/L Hemoglobin (Hb) ≥ 90 g/L Total bilirubin (TBIL) ≤ 1.5×ULN Alanine transaminase (ALT), Aspartate aminotransferase (AST)≤×ULN (for patients with liver metastasis, ≤ 5×ULN) Creatinine clearance (CrCL)≥ 60 mL/min
- 7) The subject has no fertility plan (including sperm donation and egg donation) for at least 6 months from the signing of informed consent to the last dose and voluntarily takes non-drug effective contraceptive measures;
- 8) Subjects can communicate well with the investigators, understand and comply with the requirements of the study.
Who cannot join
- 1) A severe allergy or hypersensitivity to paclitaxel or human albumin;
- 2) In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding diathymia or clotting disorders) diseases Patients with a known or present history of the disease who are deemed unsuitable for enrollment by the investigators;
- 3) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;
- 4) Pregnant or lactating female subjects;
- 5) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen/antibody positive; treponema pallidum antibody positive and rapid plasma reaction hormone (RPR) positive;
- 6) Those who used chemical small molecule anti-tumor drugs (including endocrine therapy), biological macromolecular anti-tumor drugs, biological therapy, radiotherapy or needed to combine other anti-tumor drugs for treatment during the study period within 4 weeks before the first dose;
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- 7) Electrocardiogram shows significant abnormality, and/or baseline QTcF interval is > 470 ms;
- 8) Pre-screening sensory neuropathy/peripheral neuropathy are ≥ grade 2;
- 9) Blood donation or significant blood loss (> 400 mL) within 90 days before - screening;
- 10) Ingestion of an inhibitor or inducer of CYP2C8 or CYP3A4 within 28 days prior to dosing (acceptable drug use is stable in homeostasis, that is, the dosing regimen remains unchanged; However, the use of moderate-strong inhibitory agents/moderate-strong inducers should be prohibited), or drugs (including Chinese herbs) that can affect the absorption, distribution, metabolism and excretion behavior of the study drugs or special diets (such as products containing caffeine or xanthine, grapefruit fruits and products containing grapefruit ingredients, etc.);
- 11) Those who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit ≈ 360 mL for beer, or 45 mL for spirits, or 150 mL for wine) or who could not stop drinking during the study period or who are breath-positive for alcohol;
- 12) Smoking > 5 cigarettes per day within 3 months prior to screening or smoking cannot be stopped during the study period;
- 13) Any clinically significant abnormal results in the subjects' vital signs, physical examination, clinical laboratory examination (unless otherwise specified in the protocol), 12-lead electrocardiogram (ECG) and other examination results that the investigator deems unsuitable for enrollment;
- 14) Within 6 months prior to screening, there is a history of drug abuse (except regular use of pain medications due to cancer pain) or positive drug abuse screening;
- 15) Toxicity caused by using of anti-tumor drugs prior to enrolment do not return to ≤ grade 1 or baseline levels, except for alopecia;
- 16) Subjects receiving granulocyte-stimulating growth factor treatment within 2 weeks before dosing;
- 17) Subjects who have participated in any clinical trial within 1 month before screening (start from the time of the last dose);
- 18) Any other circumstances determined by the investigator to be inappropriate are not suitable for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Yanhua Ding, Medicine Doctor, 0431-88782168, dingyanhua2003@126.com
About this study
Official title: A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients
The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.
- Conditions
- Bioequivalence
- Being tested
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound), Abraxane®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)Drug
IV infusion, 260 mg/m^2
Abraxane®Drug
IV infusion, 260 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | Experimental | The subjects randomly reveived single dose of 260 mg/m^2 of paclitaxel protein-bound particles for injectable suspension (albumin-bound) Receives: Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) |
| Abraxane® | Experimental | The subjects randomly reveived single dose of 260 mg/m^2 of Abraxane® Receives: Drug: Abraxane® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax) of total and unbound paclitaxel
Measured: 72 hours
Area under the plasma concentration versus time curve AUC0-t
Evaluation of Area under the plasma concentration versus time curve AUC0-t of total and unbound paclitaxel
Measured: 72 hours
Area under the plasma concentration versus time curve AUC0-∞
Evaluation of Area under the plasma concentration versus time curve AUC0-∞ of total and unbound paclitaxel
Measured: 72 hours
Secondary outcomes (3)
Time to peak Plasma Concentration (Tmax)
The Tmax of total and unbound paclitaxel
Measured: 72 hours
Elimination of half-life (t1/2)
The t1/2of total and unbound paclitaxel
Measured: 72 hours
Incidence of Adverse Events
Collection of adverse events
Measured: Up to 6 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start26 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096869
- Sponsor's protocol ID
- HF112-001
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07096869
- Acronym / sponsor ID
- HF112-001
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 31 Jul 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.
The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | Experimental | Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)The subjects randomly reveived single dose of 260 mg/m^2 of paclitaxel protein-bound particles for injectable suspension (albumin-bound) |
| Abraxane® | Experimental | Drug: Abraxane®The subjects randomly reveived single dose of 260 mg/m^2 of Abraxane® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as subjects, and sign informed consent prior to the commencement of any study procedure;
- 2) Male and female, ages 18-75 years both inclusive;
- 3) Subjects with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; ②This treatment criteria (NCCN guidelines and CSCO guidelines - Breast cancer) is used to determine whether the subjects are suitable for paclitaxel for injection (albumin-bound) monotherapy. ③Subjects received standard treatment without conditions and were judged to benefit from injectable paclitaxel (albumin-binding) monotherapy;
- 4) ECOG Score ≤ 2 points;
- 5) The expecting life span ≥ 3months;
Key exclusion criteria (18 listed)
- 1) A severe allergy or hypersensitivity to paclitaxel or human albumin;
- 2) In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding diathymia or clotting disorders) diseases Patients with a known or present history of the disease who are deemed unsuitable for enrollment by the investigators;
- 3) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;
- 4) Pregnant or lactating female subjects;
- 5) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen/antibody positive; treponema pallidum antibody positive and rapid plasma reaction hormone (RPR) positive;
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 |
|---|---|---|
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound)IV infusion, 260 mg/m^2 | Drug | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) |
| Abraxane®IV infusion, 260 mg/m^2 | Drug | Abraxane® |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 72 hours
Evaluation of Peak Plasma Concentration (Cmax) of total and unbound paclitaxel
Area under the plasma concentration versus time curve AUC0-t
Time frame: 72 hours
Evaluation of Area under the plasma concentration versus time curve AUC0-t of total and unbound paclitaxel
Area under the plasma concentration versus time curve AUC0-∞
Time frame: 72 hours
Evaluation of Area under the plasma concentration versus time curve AUC0-∞ of total and unbound paclitaxel
3 secondary outcomes
Time to peak Plasma Concentration (Tmax)
Time frame: 72 hours
Elimination of half-life (t1/2)
Time frame: 72 hours
Incidence of Adverse Events
Time frame: Up to 6 mouths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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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.
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 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) and Abraxane® in people with Bioequivalence, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 31 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 72 hours). The study lists 3 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 31 Jul 2025.