A Phase I, Double-blind, Randomised, Single-dose, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

SAMSON-1

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..

2018-09-19

2019-03-13

2019-03-13

Completed

Early phase I

119

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.

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2023-02-08