Metastatic Breast CancerPhase 1NCT05765357
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
A Phase 1 study testing Trastuzumab for injection and Herceptin in people with Metastatic Breast Cancer and Metastatic Gastric Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Gastric Cancer
- What is being tested?
- Trastuzumab for injection and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2017to 27 Oct 2017
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
- Healthy male subjects aged ≥ 18 years and ≤ 65 years;
- Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
- The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
- Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
Who cannot join
- History of hypertension or abnormal blood pressure at screening/baseline measurement;
- A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
- Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
- Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
- Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
- History of digestive tract perforation or digestive tract fistula;
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- Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
- Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
- Positive virology test;
- Known allergy to trastuzumab;
- Known history of allergic diseases or allergic constitution;
- Study the history of blood donation 3 months before drug infusion;
- Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
- A history of alcohol or drug abuse in the 12 months prior to screening;
- A history of mental illness;
- Subjects whose spouses plan to become pregnant;
- The study cannot be completed according to protocol requirements during the study period;
- Conditions considered unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
Official title: Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
- Being tested
- Trastuzumab for injection, Herceptin
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab for injectionDrug
Trastuzumab for injection manufactured by Chia Tai Tianqing. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
HerceptinDrug
Herceptin is the brand name of Trastuzumab for injection manufactured by Roche. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab for injection | Experimental | 4mg/kg, Single dose for intravenous infusion Receives: Drug: Trastuzumab for injection |
| Herceptin | Active comparator | 4mg/kg, Single dose for intravenous infusion Receives: Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under drug concentration - time curve (AUC0-t)
Area under the curve from time zero to the lowest detectable blood drug concentration
Measured: Within 30 minutes before administration to 1344 hours after administration
Secondary outcomes (6)
Area under drug concentration - time curve (AUC0-∞)
The area under the curve extrapolating from time zero to infinity
Measured: Within 30 minutes before administration to 1344 hours after administration
Peak concentration (Cmax)
Peak maximum plasma drug concentration
Measured: Within 30 minutes before administration to 1344 hours after administration
Time to reach maximum plasma (Tmax)
Time to reach maximum plasma concentration after dosing
Measured: Within 30 minutes before administration to 1344 hours after administration
Clearance (CL)
Percentage of the body that eliminates organ-scavenging drugs
Measured: Within 30 minutes before administration to 1344 hours after administration
half-life (T1/2)
The time it takes for serum drug concentrations to drop by half
Measured: Within 30 minutes before administration to 1344 hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution after administration
Measured: Within 30 minutes before administration to 1344 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start16 Jul 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765357
- Sponsor's protocol ID
- ZDTQ-2017-QTZDK
- Status last verified
- Apr 2017
- First submitted
- 1 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
- ClinicalTrials.gov ID
- NCT05765357
- Acronym / sponsor ID
- ZDTQ-2017-QTZDK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 13 Mar 2023 (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.
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab for injection | Experimental | Drug: Trastuzumab for injection4mg/kg, Single dose for intravenous infusion |
| Herceptin | Active comparator | Drug: Herceptin4mg/kg, Single dose for intravenous infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
- Healthy male subjects aged ≥ 18 years and ≤ 65 years;
- Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
- The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
- Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
Key exclusion criteria (18 listed)
- History of hypertension or abnormal blood pressure at screening/baseline measurement;
- A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
- Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
- Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
- Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
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 |
|---|---|---|
| Trastuzumab for injectionTrastuzumab for injection manufactured by Chia Tai Tianqing. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells. | Drug | Trastuzumab for injection |
| HerceptinHerceptin is the brand name of Trastuzumab for injection manufactured by Roche. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells. | Drug | Herceptin |
Primary outcome
Area under drug concentration - time curve (AUC0-t)
Time frame: Within 30 minutes before administration to 1344 hours after administration
Area under the curve from time zero to the lowest detectable blood drug concentration
6 secondary outcomes
Area under drug concentration - time curve (AUC0-∞)
Time frame: Within 30 minutes before administration to 1344 hours after administration
Peak concentration (Cmax)
Time frame: Within 30 minutes before administration to 1344 hours after administration
Time to reach maximum plasma (Tmax)
Time frame: Within 30 minutes before administration to 1344 hours after administration
Clearance (CL)
Time frame: Within 30 minutes before administration to 1344 hours after administration
half-life (T1/2)
Time frame: Within 30 minutes before administration to 1344 hours after administration
Apparent volume of distribution (Vd/F)
Time frame: Within 30 minutes before administration to 1344 hours after administration
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 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Trastuzumab for injection and Herceptin in people with Metastatic Breast Cancer and Metastatic Gastric Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 5 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: finished, as of the sponsor's last update on 13 Mar 2023. 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?
Area under drug concentration - time curve (AUC0-t) (time frame: Within 30 minutes before administration to 1344 hours after administration). 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 Mar 2023.