Status:
COMPLETED
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
Lead Sponsor:
Prestige Biopharma Limited
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intr...
Detailed Description
This is a double-blind, randomized, three-arm, parallel-group, single-dose study. A total of 120 evaluable subjects are required.
Eligibility Criteria
Inclusion
- Non-smoking healthy male subjects, 18-50 years old inclusive
- Body Mass index is between 19 to 30 kg/m2, inclusive
- NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.
- For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.
- Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.
- Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
Exclusion
- Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)
- Systolic blood pressure \> 140 mmHg or \< 90 mmHg , or diastolic blood pressure \> 90 mmHg or \<50 mmHg
- Proteinuria (with a urine dipstick value of 2+ or above)
- Coagulation abnormalities ( i.e., INR \> 2x ULN)
- Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.
- Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS
- Positive test result for drugs of abuse or alcohol breathing test.
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or 2.
- Donated or lost \> 500ml of blood in the previous 3 months
- Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).
- Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.
- Unwillingness or inability to comply with the study protocol for any reason.
- Male subject whose partner is pregnant.
- History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- History of alcohol and/or drug abuse within 12 months of screening.
Key Trial Info
Start Date :
September 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03390673
Start Date
September 19 2018
End Date
March 13 2019
Last Update
November 19 2024
Active Locations (2)
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1
Auckland Clinical Studies
Auckland, New Zealand, 1010
2
Christchurch Clinical Studies Trust Ltd
Christchurch, New Zealand, 8011