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

NCT ID: NCT03390673

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2019-03-13

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 intravenous administration of a single dose..

Detailed Description

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

HD204

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

Group Type: EXPERIMENTAL

HD204

Intervention Type: DRUG

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

EU-licensed Avastin

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

Group Type: ACTIVE_COMPARATOR

Avastin

Intervention Type: DRUG

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

US-licensed Avastin

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

Group Type: ACTIVE_COMPARATOR

Avastin

Intervention Type: DRUG

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

Interventions

HD204

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

Intervention Type: DRUG

Avastin

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

Intervention Type: DRUG

Other Intervention Names

Bevacizumab; Bevacizumab

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Prestige Biopharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Auckland Clinical Studies

Auckland, , New Zealand

Christchurch Clinical Studies Trust Ltd

Christchurch, , New Zealand

Countries

New Zealand

References

Demarchi M, Coliat P, Barthelemy P, Schott R, BenAbdelghani M, Kim M, Hii JCS, Feyaerts P, Ang FRX, Derde MP, Deforce F, Petit T, Schwabe C, Wynne C, Park LS, Pivot X. A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab. PLoS One. 2021 Sep 23;16(9):e0248222. doi: 10.1371/journal.pone.0248222. eCollection 2021.

Reference Type: DERIVED

PMID: 34555031 (View on PubMed)

Other Identifiers

SAMSON-1

Identifier Type: -

Identifier Source: org_study_id