A study assessing the similarity of Avastin (Registered Trademark) and the trial drug BAT1706.

Randomized, double-blind, single-dose, 3-arm parallel design comparative pharmacokinetic and safety Phase I study of BAT1706 versus EU-sourced Avastin (Registered Trademark) and US-sourced Avastin (Registered Trademark) administered in healthy subjects

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000283471

Enrollment

129

Registered

2016-03-04

Start date

2016-03-15

Completion date

2016-07-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Avastin (Registered Trademark) is currently used in many countries for the treatment of certain cancers. The primary purpose of this study is to investigate the similarities in the manner in which a new drug, BAT1706 is distributed around the body compared with European approved and USA licensed Avastin. Who is it for? You may be eligible to join this study if you are a healthy male adult from 18 to 50 years of age with a BMI of 19.0 to 29.0 kg/m2 and body weight of 65 to 100kg. Participants enrolled in this study will be randomly allocated (by chance) to receive either the new BAT1706 drug, USA licensed Avastin or European approved Avastin. All participants will receive a single dose which is adjusted for their weight. Participants will have a number of blood samples taken until Day 99 after the dose and will be monitored for side effects for 99 Days. It is hoped that the findings of this study will provide information regarding the similarity of drug distribution and safety of the new drug BAT1706 compared to currently used Avastin for the treatment of certain types of cancer.

Interventions

Three Bevacizumab Preperations Arm 1:BAT1706 100 mg in 4 mL - 1mg/kg Recombinant humanised monoclonal antibody - bevacizumab 1 time only Intravenous infusion. Arm 2: Avastin (Registered Trademark) United States-licenced (bevacizumab) 100 mg in 4 mL- 1mg/kg Recombinant humanised monoclonal antibody - bevacizumab 1 time only Intravenous infusion. Arm 3: Avastin (Registered Trademark) European Approved (bevacizumab) 100 mg in 4 mL- 1mg/kg Recombinant humanised monoclonal antibody - bevacizumab 1

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Adult males aged 18 to 50 years inclusive and between 19 and 28 kg/m2 body mass index (BMI) and body weight greater than and equal to 65 and less than and equal to 100 kg. 2. Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram (ECG). 3. Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinically relevant. 4. Subjects who are non-smokers and have not regularly used tobacco or nicotine containing products for at least 3 months preceding screening and have a <10 pack year smoking history. 5. Must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an intra-uterine device, barrier method with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, or a bilateral tubal ligation, unless their partners are infertile from the time of the administration of investigational product (IP) until completion of study procedures. 6. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures including standardised meals.

Exclusion criteria

1. Have a history of and/or current clinically significant gastrointestinal (including diverticulitis, stomach ulcers), renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or allergic disease excluding mild asymptomatic seasonal allergies. 2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator (e.g., inability to understand and/or comply with study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study). 3. History or current clinically significant (in the opinion of the Investigator) allergy, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations (e.g. hypersensitivity to any recombinant human or humanized antibodies) or comparable drugs. 4. Any inherited predisposition to bleeding or to thrombosis or history of non-traumatic hemorrhage (i.e. any hemorrhage requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count <150, 000 per micro Litre) or an international normalized ratio higher than 1.5 at screening. 5. History of cancer including lymphoma, leukemia and skin cancer. 6. Intended participation in contact/collision sports from admission until Day 30. 7. Live virus vaccination within 12 weeks prior to screening or intention to receive live virus vaccination during the study until the final follow-up visit. 8. Prior exposure to any Investigational drug in any clinical trial within 3 months of study drug administration or are currently participating in another clinical study of an investigational drug, or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study. 9. Any prior exposure to bevacizumab or VEGF targeted treatment. 10. Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration. 11. Intake of prescribed or over-the-counter drugs including non-steroidal anti-inflammatory drugs (NSAID) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration. Any dose of aspirin in the last 14 days before administration of the study drug and for the duration of the study is not allowed. 12. Intake of herbal remedies within 14 days prior to study drug administration. 13. Blood or blood product donation >500 mL in the 1 month before screening or the intention to donate blood or blood products during the study (through Day 99). 14. Abnormal and clinically relevant (in the opinion of the Investigator) ECG or corrected QT value (Bazett correction) longer than 450 ms. 15. Subjects with abnormal blood pressure (systolic blood pressure less than and equal to 90 and greater than and equal to 140 mmHg, diastolic blood pressure less than and equal to 50 and greater than and equal to 90 mmHg) or pulse rate less than and equal to 45 and greater than and equal to 100 bpm at screening or admission to the clinical center (Day -1). 16. Subjects with known hypertension or relevant family history of hypertension, or history of relevant orthostatic hypotension, fainting spells, or blackouts as judged by the Investigator. 17. Total cholesterol >7.5 mmol/L at screening or glucose >7.7 mmol/L at screening or admission. 18. Impaired liver function at screening or admission as determined by: ? Serum alanine aminotransferase and/or aspartate aminotransferase >1.5 x upper limit of normal (ULN) at screening or admission. Subjects with values between ULN and 1.5 x ULN may be included in the study if considered not clinically significant by the Investigator. 19. Any clinically significant chronic or acute infection ongoing at screening or admission to the clinical center or subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C ribonucleic acid (RNA) or human immunodeficiency virus (HIV) 1 and 2 tests at screening. 20. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. 21. Poor oral hygiene that may require surgical intervention during the study or any planned dental surgical interventions during the clinical trial. 22. History of alcohol abuse or a positive alcohol test on screening or admission to the clinical center. 23. No alcoholic beverages from 48 prior to drug administration until discharge from the study center on Day 3. 24. History of drug abuse or positive drug test at screening or admission to the clinical center as indicated by a positive urinary drug test. Subjects are to refrain from drugs of abuse for the duration of the study. 25. Inability to refrain from smoking during days of confinement at the study center and for the duration of the study (through Day 99). 26. Any persons who are: an employee of the Principal Investigator, clinical center, clinical research organisation (CRO) or Sponsor a relative of an employee of the clinical center, the Investigators, CRO or the Sponsor.

Outcome results