NSCLCPhase 1NCT03030430
Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects
A Phase 1 study testing BAT1706 injection, EU-sourced Avastin and US-sourced Avastin in people with NSCLC, run by Bio-Thera Solutions at 1 site in New Zealand.
Trial summary
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators. 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
- NSCLC
- What is being tested?
- BAT1706 injection, EU-sourced Avastin and US-sourced Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNew Zealand
- Study dates
- 15 Mar 2016to 28 Jun 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
- Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
- Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 ECG.
- Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinical relevant.
Who cannot join
- Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
- Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator.
- History or current clinically significant, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations or comparable drugs.
- Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
- Intake of herbal remedies within 14 days prior to study drug administration.
- History of alcohol abuse or a positive alcohol test on screening or admission to the clinical center.
- Any persons who are:an employee of the Principal Investigator, clinical center, Clinical Research Organization (CRO) or Sponsor;a relative of an employee of the clinical center, the Investigators, CRO or the Sponsor.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Clinical Studies Trust Ltd (CCST)
Christchurch, 8011
About this study
Official title: Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.
Read the detailed description
This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.
A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.
Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments.
There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation.
After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.
- Conditions
- NSCLC
- Being tested
- BAT1706 injection, EU-sourced Avastin, US-sourced Avastin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT1706 injectionBiological
1mg/kg, IV on day 1
EU-sourced AvastinBiological
1mg/kg, IV on day 1
US-sourced AvastinBiological
1mg/kg, IV on day 1
| Study group | Role | What they receive |
|---|---|---|
| BAT1706 | Experimental | BAT1706 injection Receives: Biological: BAT1706 injection |
| EU-sourced Avastin | Active comparator | EU-sourced Avastin Receives: Biological: EU-sourced Avastin |
| US-sourced Avastin | Active comparator | US-sourced Avastin Receives: Biological: US-sourced Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under curve (AUC)0~∞
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start15 Mar 2016
- Primary completion16 May 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Wynne, Medical Doc, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030430
- Sponsor's protocol ID
- BAT-1706-001
- Status last verified
- Jul 2018
- First submitted
- 20 Jan 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
Publications
Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin(R)) in Healthy Male Subjects. BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7.
PubMed 31016568
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03030430
- Acronym / sponsor ID
- BAT-1706-001
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 establish PK similarity in the treatment of BAT1706 and comparators.
Detailed description
This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.
A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.
Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments.
There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation.
After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAT1706 | Experimental | Biological: BAT1706 injectionBAT1706 injection |
| EU-sourced Avastin | Active comparator | Biological: EU-sourced AvastinEU-sourced Avastin |
| US-sourced Avastin | Active comparator | Biological: US-sourced AvastinUS-sourced Avastin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
- Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 ECG.
- Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinical relevant.
Key exclusion criteria (7 listed)
- Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
- Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator.
- History or current clinically significant, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations or comparable drugs.
- Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
- Intake of herbal remedies within 14 days prior to study drug administration.
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 |
|---|---|---|
| BAT1706 injection1mg/kg, IV on day 1 | Biological | BAT1706 |
| EU-sourced Avastin1mg/kg, IV on day 1 | Biological | EU-sourced Avastin |
| US-sourced Avastin1mg/kg, IV on day 1 | Biological | US-sourced Avastin |
Primary outcome
area under curve (AUC)0~∞
Time frame: 4 months
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 30 Jul 2018.
- Derived from this study: PubMed 31016568Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin(R)) in Healthy Male Subjects. BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7.
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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.
Chris Wynne, Medical Doc principal investigator
Director
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 BAT1706 injection, EU-sourced Avastin and US-sourced Avastin in people with NSCLC, run by Bio-Thera Solutions at 1 site in New Zealand.
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 3 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 30 Jul 2018. 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 New Zealand. 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 curve (AUC)0~∞ (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030430, which also lists 1 linked publication.
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 30 Jul 2018.