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

Prestige Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Avastin; Drug: HD204

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390673

SAMSON-1

Details and patient eligibility

About

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..

Full description

This is a double-blind, randomized, three-arm, parallel-group, single-dose study. A total of 120 evaluable subjects are required.

Enrollment: 119 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 3 patient groups

HD204

Experimental group

Description:

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Treatment:

Drug: HD204

EU-licensed Avastin

Active Comparator group

Description:

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Treatment:

Drug: Avastin

US-licensed Avastin

Active Comparator group

Description:

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Treatment:

Drug: Avastin