Rectal CancerPhase 1NCT05476341
A Phase I Clinical Trial of Bevacizumab Injection
A Phase 1 study testing Bevacizumab injection and Bevacizumab injection（Avastin） in people with Rectal Cancer and Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. 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
- Rectal Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- Bevacizumab injection and Bevacizumab injection（Avastin）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2017to 18 Aug 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
- 1 Fully understand the purpose of the test, and basically understand the pharmacological effects and possible adverse reactions of the research drugs; Voluntarily sign written informed consent in accordance with the spirit of the Helsinki declaration.
- 2 Healthy male subjects aged ≥ 18 and ≤ 65.
- 3 Weight ≥ 50 kg and ≤ 80 kg, body mass index (BMI) ≥ 18 and ≤ 28kg/m2.
- 4 Each system examination index is within the normal range, or the examination result is abnormal, but it is judged by the researcher to be of no clinical significance.
- 5 The subjects agreed to use reliable contraceptives for themselves and their partners during the study period and within 6 months after the infusion of the study drug(such as abstinence, sterilization, contraceptive pills, injection of contraceptive medroxyprogesterone or subcutaneous implantation contraception, etc).
Who cannot join
- 1 Have a history of hypertension or abnormal blood pressure during screening / baseline measurement(Repeated measurements on the same day confirmed that systolic blood pressure [SBP] > 140 mmHg and / or diastolic blood pressure [DBP] > 90 mmHg).
- 2 Clinically significant proteinuria (routine urine examination, urine protein 2+ and above) or history of proteinuria assessed by the investigator.
- 3 Have received any antibody or protein therapy targeting VEGF or VEGF receptor in the past 1 year.
- 4 Used any biological products or vaccinated with live virus vaccine within 3 months before the infusion of the study drug, or used any monoclonal antibody within 12 months.
- 5 Have hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis or bleeding.
- 6 Have a history of gastrointestinal perforation or fistula.
Show all 18Show fewer
- 7 Unhealed wound ulcer or fracture, or major surgery within the first 2 months of randomization, or major surgery expected during the study period or within 2 months after the end of the study.
- 8 Use prescription or over-the-counter drugs or nutritional health products, and the use time is within 5 half lives of the drugs or nutritional health products or within 2 weeks before the use of the study drugs (the time limit is whichever is longer).Herbal health products should be stopped 28 days before using the study drug.
- 9 Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody are tested positive.
- 10 Known allergy to bevacizumab or any of its excipients.
- 11 People with known history of allergic diseases or allergic constitution.
- 12 There was a history of blood donation 3 months before the infusion of the study drug.
- 13 Have been treated with any other research drugs or participated in another intervention clinical trial within 2 months before screening.
- 14 Have a history of alcohol or drug abuse within 12 months before screening; The subjects were unable to quit drinking within 72 hours before administration and throughout the trial.
- 15 Have a history of mental illness.
- 16 Subjects whose spouses plan to conceive.
- 17 Unable to follow the protocol requirements to complete the study during the study.
- 18 Other researchers think it is not suitable to be included in the group
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130000
About this study
Official title: A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.
- Conditions
- Rectal Cancer, Lung Cancer, Ovarian Cancer, Cervical Cancer, Glioblastoma
- Being tested
- Bevacizumab injection, Bevacizumab injection（Avastin）
- Medical subject headings
- Rectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab injectionDrug
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
Bevacizumab injection（Avastin）Drug
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab injection | Experimental | On the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes). Receives: Drug: Bevacizumab injection |
| Bevacizumab injection（Avastin） | Active comparator | On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes). Receives: Drug: Bevacizumab injection（Avastin） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration-area under time curve（AUC0-t）
Area under the blood concentration time curve from 0 hour to the collection time t of the last measurable concentration
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Secondary outcomes (6)
Plasma concentration-area under time curve（AUC0-∞）
Area under the blood concentration time curve from 0 hour to inf (infinity)
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Peak concentration (Cmax)
Maximum plasma concentration observed after administration
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events
Incidence of adverse events assessed by CTCAE v4.0
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Number of adverse events related to the study drug
Number of adverse events evaluated by CTCAE v4.0
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events related to the study drug
Incidence of study drug-related adverse events assessed by CTCAE v4.0
Measured: Within 30 minutes before administration to 1680 hours (day 71)
ADA positive rate
When anti drug antibody (ADA) is positive, neutralizing antibody (NAB) test is performed
Measured: Within 30 minutes before administration to 1680 hours (day 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start6 Apr 2017
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- 98 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
- NCT05476341
- Sponsor's protocol ID
- ZDTQ-2017-BFZDK
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05476341
- Acronym / sponsor ID
- ZDTQ-2017-BFZDK
- Conditions
- Rectal Cancer, Lung Cancer, Ovarian Cancer, Cervical Cancer, Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 27 Jul 2022 (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.
Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.
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 |
|---|---|---|
| Bevacizumab injection | Experimental | Drug: Bevacizumab injectionOn the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes). |
| Bevacizumab injection（Avastin） | Active comparator | Drug: Bevacizumab injection（Avastin）On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 Fully understand the purpose of the test, and basically understand the pharmacological effects and possible adverse reactions of the research drugs; Voluntarily sign written informed consent in accordance with the spirit of the Helsinki declaration.
- 2 Healthy male subjects aged ≥ 18 and ≤ 65.
- 3 Weight ≥ 50 kg and ≤ 80 kg, body mass index (BMI) ≥ 18 and ≤ 28kg/m2.
- 4 Each system examination index is within the normal range, or the examination result is abnormal, but it is judged by the researcher to be of no clinical significance.
- 5 The subjects agreed to use reliable contraceptives for themselves and their partners during the study period and within 6 months after the infusion of the study drug(such as abstinence, sterilization, contraceptive pills, injection of contraceptive medroxyprogesterone or subcutaneous implantation contraception, etc).
Key exclusion criteria (18 listed)
- 1 Have a history of hypertension or abnormal blood pressure during screening / baseline measurement(Repeated measurements on the same day confirmed that systolic blood pressure [SBP] > 140 mmHg and / or diastolic blood pressure [DBP] > 90 mmHg).
- 2 Clinically significant proteinuria (routine urine examination, urine protein 2+ and above) or history of proteinuria assessed by the investigator.
- 3 Have received any antibody or protein therapy targeting VEGF or VEGF receptor in the past 1 year.
- 4 Used any biological products or vaccinated with live virus vaccine within 3 months before the infusion of the study drug, or used any monoclonal antibody within 12 months.
- 5 Have hereditary bleeding tendency or 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 |
|---|---|---|
| Bevacizumab injectionRecombinant humanized monoclonal antibody injection against human vascular endothelial growth factor | Drug | Bevacizumab injection |
| Bevacizumab injection（Avastin）Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor | Drug | Bevacizumab injection（Avastin） |
Primary outcome
Plasma concentration-area under time curve（AUC0-t）
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Area under the blood concentration time curve from 0 hour to the collection time t of the last measurable concentration
6 secondary outcomes
Plasma concentration-area under time curve（AUC0-∞）
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Peak concentration (Cmax)
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Number of adverse events related to the study drug
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
Incidence of adverse events related to the study drug
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
ADA positive rate
Time frame: Within 30 minutes before administration to 1680 hours (day 71)
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 27 Jul 2022.
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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 Bevacizumab injection and Bevacizumab injection（Avastin） in people with Rectal Cancer and Lung 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 27 Jul 2022. 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?
Plasma concentration-area under time curve（AUC0-t） (time frame: Within 30 minutes before administration to 1680 hours (day 71)). 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 27 Jul 2022.