Healthy Male SubjectsPhase 1NCT05005455
Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
A Phase 1 study testing bevacizumab with new manufacturing process. and bevacizumab with old manufacturing process. in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- bevacizumab with new manufacturing process. and bevacizumab with old manufacturing process.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 28 Jan 2022
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
- Age≥18 years and ≤50 years, healthy male subjects;
- Weight ≥ 50kg and ≤ 100kg,BMI≥ 19kg/m2 and < 28 kg/m2
- Clinical examinations in the screening period are normal or abnormal without clinical significance.
- Agree to take effective contraceptive measures throughout the study period and until at least 6 months after receiving the last dose of study drug
Who cannot join
- Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
- Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after end of the study.
- Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
- Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.
- Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution.
- History of blood donation within 3 months before the first dose of study drug.
- Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Soochow university
Suzhou, Jiangsu, 215006
About this study
Official title: A Randomized, Double-blind, Parallel Controlled, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetic Similarity, Safety, and Immunogenicity of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
- Conditions
- Healthy Male Subjects
- Being tested
- bevacizumab with new manufacturing process., bevacizumab with old manufacturing process.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab with new manufacturing process.Drug
3mg/kg,I.V.,single dose
bevacizumab with old manufacturing process.Drug
3mg/kg,I.V.,single dose
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab with old manufacturing process. | Active comparator | Not described Receives: Drug: bevacizumab with old manufacturing process. |
| bevacizumab with new manufacturing process. | Experimental | Not described Receives: Drug: bevacizumab with new manufacturing process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure:Area Under the Curve(AUC0-∞)
Measured: 84days
Secondary outcomes (8)
Area Under the Curve(AUClast)
Measured: 84days
Maximum Concentration (Cmax)
Measured: 84days
Volume of distribution (V)
Measured: 84days
Total body clearance (CL)
Measured: 84days
Elimination half-life (t1/2)
Measured: 84days
Time at which maximum concentration occurred (Tmax)
Measured: 2016days
Incicende of Adverse Events (AEs)
Measured: 98days
Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb）
Measured: 98days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start30 Jul 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005455
- Sponsor's protocol ID
- CIBI305K101
- Status last verified
- Jun 2022
- First submitted
- 17 Jul 2021
- Last updated
- 10 Jun 2022
- 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 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Controlled, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetic Similarity, Safety, and Immunogenicity of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05005455
- Acronym / sponsor ID
- CIBI305K101
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 13 Aug 2021 (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 purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab with old manufacturing process. | Active comparator | Drug: bevacizumab with old manufacturing process. |
| bevacizumab with new manufacturing process. | Experimental | Drug: bevacizumab with new manufacturing process. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
- Age≥18 years and ≤50 years, healthy male subjects;
- Weight ≥ 50kg and ≤ 100kg,BMI≥ 19kg/m2 and < 28 kg/m2
- Clinical examinations in the screening period are normal or abnormal without clinical significance.
- Agree to take effective contraceptive measures throughout the study period and until at least 6 months after receiving the last dose of study drug
Key exclusion criteria (7 listed)
- Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
- Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after end of the study.
- Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
- Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.
- Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution.
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 with new manufacturing process.3mg/kg,I.V.,single dose | Drug | bevacizumab with new manufacturing process. |
| bevacizumab with old manufacturing process.3mg/kg,I.V.,single dose | Drug | bevacizumab with old manufacturing process. |
Primary outcome
Primary Outcome Measure:Area Under the Curve(AUC0-∞)
Time frame: 84days
8 secondary outcomes
Area Under the Curve(AUClast)
Time frame: 84days
Maximum Concentration (Cmax)
Time frame: 84days
Volume of distribution (V)
Time frame: 84days
Total body clearance (CL)
Time frame: 84days
Elimination half-life (t1/2)
Time frame: 84days
Time at which maximum concentration occurred (Tmax)
Time frame: 2016days
Incicende of Adverse Events (AEs)
Time frame: 98days
Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb）
Time frame: 98days
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 10 Jun 2022.
- 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 bevacizumab with new manufacturing process. and bevacizumab with old manufacturing process. in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) 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 7 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 10 Jun 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?
Primary Outcome Measure:Area Under the Curve(AUC0-∞) (time frame: 84days). 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 10 Jun 2022.