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

NCT03390673 | Completed Phase 1

• 1 other identifier: SAMSON-1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

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..

Conditions

Healthy Volunteers

Keywords

randomized; double-blind

Outcome Measures

Primary Outcomes (1)

• Area under Curve (AUC, Pharmacokinetics)

  Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin

  up to week 12

Secondary Outcomes (2)

• Immunogenicity

  Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

  From Day 1 through study completion (Day 95)

Study Arms (3)

HD204

EXPERIMENTAL

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

Drug: HD204

EU-licensed Avastin

ACTIVE COMPARATOR

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

Drug: Avastin

US-licensed Avastin

ACTIVE COMPARATOR

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

Drug: Avastin

Interventions

HD204 DRUG

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

Also known as: Bevacizumab

HD204

Avastin DRUG

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

Also known as: Bevacizumab

EU-licensed Avastin; US-licensed Avastin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prestige Biopharma Limited: lead

Study Sites (2)

Auckland Clinical Studies

Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 34555031 DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: September 19, 2018
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: November 19, 2024

Record last verified: 2023-02

Locations

NZ (2)