HealthyPhase 1NCT03115762
Pharmacokinetics and Safety Study of ASKB1202 in Chinese Healthy Subjects
A Phase 1 study testing bevacizumab and ASKB1202 in people with Healthy, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd..
Trial summary
This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of ASKB1202 compared to bevacizumab sold in China and Europe. 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
- What is being tested?
- bevacizumab and ASKB1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Healthy males,aged 18 to 50 years. 2.A complete medical history, including disease history,physical examination, vital signs, 12-lead electrocardiogram (ECG), and chest X-ray image.
- 3.Clinical laboratory tests is normal or the abnormality is not clinical significant determined by researchers.
- 4.The subjects were willing to take effective contraceptive measures within 2 months before use of the drug and 6 months after.
- 5.The subjects could understand the procedures and methods of this study, were willing to strictly abide the clinical trial plan to complete the test, sign the Informed Notice.
Who cannot join
- 1.Any evidence of a historical or existing clinically relevant concomitant disease, as determined by researchers.
- 2.Acute,chronic active infections during screening of the study and admission(1 day before treatment),or has a history of active tuberculosis.
- 3.Hemorrhaged or donated blood (including the components of blood donation)， or received blood transfusion ≥400 mL within 3 months before screening；Hemorrhaged or donated blood (including the components of blood donation) ≥200 mL within a month before the screening .
- 4.Any finding of abnormality which has clinical significance during the screening of the clinical tests determined by researchers.
- 5.Currently suffering from hypertension,abnormal blood pressure during study screening and hospital admission(1 day before use of drug):systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- 6.Any disease causes it to increase the risk of bleeding or thrombosis, such as bleeding or thrombosis genetic predisposition, or has a history of traumatic hemorrhage, thromboembolic events, blood coagulation disease and thrombocytopenia (platelet count <100000/L) or international standardization ratio (INR) is higher than 1.44.
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- 7.Suffered or suffering from clinical significant atopic allergy, hypersensitivity or allergic reaction, including known or suspected sensitive to one component in drug; abnormal serum immunoglobulin E (IgE) determined by researchers.
- 8.Abnormal electrocardiogram (ECG) with clinical significance, such as QTc interphase is greater than 450 milliseconds.
- 9.A history of gastrointestinal perforation or any fistula. 10.Has a wound without healing or fracture in study screening and admission. 11.Orthostatic hypotension, syncope and dizziness or has a history of shock caused by any reason.
- 12.Suffered from malignant tumors (except that controlled basal cell carcinoma and squamous cell carcinoma).
- 13.Has been vaccinated within 4 weeks before screening , or plan to get the vaccine during the study period.
- 14.Has a history of taking beacizumab or anti VEGF targeted agents or having the antibody of anti VEGF.
- 15.Participated in another trial within three months prior to administration or had a monoclonal antibody therapy within twelve months prior to administration.
- 16.Received a surgery within 28 days prior to administration, including dental suture or wound dehiscence, or plan to undergo surgery including dental surgery during the study and 60 days after the last administration of the protocol specified treatment.
- 17.Used any drug that is harmful to major organs within 3 months before administration,or use any drug within 14 days prior to participation.
- 18.Smoker who smoked >5 cigarettes per day within 3 months prior to the research and unable to refrain from smoking during the research.
- 19.History of alcohol abuse(drink alcohol more than 14 units a week [1 unit = 285 mL beer or 25 mL of liquor or 100 mL of wine); positive result for alcohol breath test within 24h before treatment;or unable to refrain from drinking during the study.
- 20.History of taking drugs or drug abuse;or positived result for drug screening;or unable to refrain from drug abuse during the study.
- 21.Positive hepatitis b surface antigen , hepatitis c antibody , HIV antibody and syphilis antibody.
- 22.Any condition that not suitable to anticipate the research or bring obvious risks to the subjects according to researchers.
About this study
Official title: Pharmacokinetics,Safety and Immunogenicity of ASKB1202 in Chinese Healthy Subjects: a Randomized, Double-blinded, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of ASKB1202 compared to bevacizumab sold in China and Europe.
- Conditions
- Healthy
- Being tested
- bevacizumab, ASKB1202
- Keywords
- ASKB1202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells
ASKB1202Biological
| Study group | Role | What they receive |
|---|---|---|
| ASKB1202 | Experimental | Subject to receive one intravenous (i.v.) infusion of ASKB1202 Receives: Biological: ASKB1202 |
| bevacizumab A | Active comparator | Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in China Receives: Biological: bevacizumab |
| bevacizumab B | Active comparator | Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in Europe Receives: Biological: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum measured concentration of the analyte in plasma
Measured: up to 100 days
AUC0-t
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Measured: up to 100 days
AUC0-∞
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: up to 100 days
Secondary outcomes (2)
Tmax
Time to peak
Measured: up to 100 days
t1/2
Terminal-phase elimination half-life
Measured: up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJun 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115762
- Sponsor's protocol ID
- ASK-LC-B1202-1
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics,Safety and Immunogenicity of ASKB1202 in Chinese Healthy Subjects: a Randomized, Double-blinded, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
- ClinicalTrials.gov ID
- NCT03115762
- Acronym / sponsor ID
- ASK-LC-B1202-1
- Conditions
- Healthy
- Keywords
- ASKB1202
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 14 Apr 2017 (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 trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of ASKB1202 compared to bevacizumab sold in China and Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASKB1202 | Experimental | Biological: ASKB1202Subject to receive one intravenous (i.v.) infusion of ASKB1202 |
| bevacizumab A | Active comparator | Biological: bevacizumabSubject to receive one intravenous (i.v.) infusion of bevacizumab sold in China |
| bevacizumab B | Active comparator | Biological: bevacizumabSubject to receive one intravenous (i.v.) infusion of bevacizumab sold in Europe |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1.Healthy males,aged 18 to 50 years. 2.A complete medical history, including disease history,physical examination, vital signs, 12-lead electrocardiogram (ECG), and chest X-ray image.
- 3.Clinical laboratory tests is normal or the abnormality is not clinical significant determined by researchers.
- 4.The subjects were willing to take effective contraceptive measures within 2 months before use of the drug and 6 months after.
- 5.The subjects could understand the procedures and methods of this study, were willing to strictly abide the clinical trial plan to complete the test, sign the Informed Notice.
Key exclusion criteria (20 listed)
- 1.Any evidence of a historical or existing clinically relevant concomitant disease, as determined by researchers.
- 2.Acute,chronic active infections during screening of the study and admission(1 day before treatment),or has a history of active tuberculosis.
- 3.Hemorrhaged or donated blood (including the components of blood donation)， or received blood transfusion ≥400 mL within 3 months before screening；Hemorrhaged or donated blood (including the components of blood donation) ≥200 mL within a month before the screening .
- 4.Any finding of abnormality which has clinical significance during the screening of the clinical tests determined by researchers.
- 5.Currently suffering from hypertension,abnormal blood pressure during study screening and hospital admission(1 day before use of drug):systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
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 |
|---|---|---|
| bevacizumabrecombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells | Biological | bevacizumab A, bevacizumab B |
| ASKB1202 | Biological | ASKB1202 |
Primary outcome
Cmax
Time frame: up to 100 days
Maximum measured concentration of the analyte in plasma
AUC0-t
Time frame: up to 100 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
AUC0-∞
Time frame: up to 100 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
2 secondary outcomes
Tmax
Time frame: up to 100 days
t1/2
Time frame: up to 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bevacizumab and ASKB1202 in people with Healthy, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd..
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Cmax (time frame: up to 100 days). 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 14 Apr 2017.