A bioequivalence study of a bevacizumab biosimilar in healthy male subjects

Phase 1

• Registration Number: CTRI/2019/02/017428
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Normal, healthy, male, adult, human, male subjects between 18 to 45 years of age (both inclusive) with a body mass index (BMI) within the range of 18 to 30 kg per meter square and having a body weight greater than 50 kg.

2. Not having any significant disease or abnormal findings during screening, medical history, clinical examination, vital sign examination (Pulse rate, blood pressure, Respiratory rate and temperature), laboratory evaluations, 12-lead ECG and X-ray chest

3. Capable of communicating effectively with study personnel.

4. Has the willingness to adhere to the protocol requirements.

5. Subjects should be willing to use adequate contraception and not donate sperm from admission until 6 months post dosing.

6. Able to understand and give written informed consent for participation in the trial.

Exclusion Criteria

1. Known hypersensitivity to the study drug or its constituents.

2. Earlier treatment with an anti-VEGF antibody or any other antibody or protein targeting the VEGF receptor (bevacizumab, ranibizumab or related products).

3. A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percentage distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.

4. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.

5. Donation of blood (1 unit or 350 mL) or plasma or equivalent or has undergone surgery in the last 3 months prior to dosing.

6. Current Smoker, or was a smoker within last six months prior to start of the study.

7. Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B (HBsAg, HBcIgM), hepatitis C, or HIV antibody (I & II) found during medical screening.

8. Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the first dose of study medication.

9. History or presence of other systemic disorders or diseases (e.g., hemopoietic, renal, hepatic, cardiovascular, respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).

10. Significant illness within two (2) weeks prior to initial dosing.

11. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.

12. Subject who underwent surgery and/or suturing for dental procedure or wound dehiscence within 90 days of dosing. Subject who are required to undergo any surgery or dental procedure during the conduct of the study.

13. Subjects with history of fracture.

14. Subject with history of bleeding disorders, thromboembolic condition, gastrointestinal perforations or any fistulae.

15. History of cerebrovascular accidents, transient ischaemic attacks, and myocardial infarction.

16. A history of difficulty in donating blood.

17. Using anticoagulant drugs, or anti-platelet drugs (Aspirin, NSAID etc.), or history of haemoptysis, thrombotic or haemorrhagic events in the past 6 months.

18. Ingestion or use of any prescribed medication at any time within 1 month prior to dosing. Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body).

19. Treated with a vaccine in the last 3 months or a monoclonal antibody in the last 12 months.

20. Subject with hypertension (defined as systolic BP of greater than 140 mmHg and diastolic BP of less than 90 mmHg).

21. Subjects with proteinuria.

22. Any clinically significant laboratory finding at the time of screening

23. Consumption of grape fruit or grape fruit products within 72 hours prior to dosing

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparision of the pharmacokinetic parameters of the test product with reference productsTimepoint: Pre-dose and at, 1.500, 2.000, 4.000, 6.000, 8.000, 12.000, 24.000 (day 2), 48.000 (day 3), 96.000 (day 5), 168.000 (day 8), 312.000 (day 14), 480.000 (day 21), 648.000 (day 28), 984.000 (day 42), 1320.000 (day 56), 1656.000 (day 70),1992.000 (day 84) and 2376.000 (day 100) hr post dose

Secondary Outcome Measures

Name	Time	Method
Comparision of the immunogenicity of the test product with reference products <br/ ><br> <br/ ><br>Comparision of the safety and tolerability of the test product with reference productsTimepoint: For immunogenicity <br/ ><br>pre-dose and at day 8, day 14, day 21, day 42, day 84 and at the end of the study (after last ambulatory sample) (day 100) <br/ ><br> <br/ ><br>For Safety and tolerability <br/ ><br>Throught the study