To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

• Status: Completed
• Trial end date: 2019-03-13
• Target enrollment: 0
• Participant gender: Male

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 intravenous administration of a single dose..

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prestige Biopharma Limited; Prestige Biopharma Ltd
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.