- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03390673
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
February 6, 2023 updated by: Prestige Biopharma Limited
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
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..
Study Overview
Detailed Description
This is a double-blind, randomized, three-arm, parallel-group, single-dose study.
A total of 120 evaluable subjects are required.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Auckland, New Zealand, 1010
- Auckland Clinical Studies
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Christchurch, New Zealand, 8011
- Christchurch Clinical Studies Trust Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HD204
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
|
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Names:
|
ACTIVE_COMPARATOR: EU-licensed Avastin
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
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Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Names:
|
ACTIVE_COMPARATOR: US-licensed Avastin
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
|
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under Curve (AUC, Pharmacokinetics)
Time Frame: up to week 12
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Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin
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up to week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)
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Incidence of anti-bevacizumab antibodies
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Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)
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Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Time Frame: From Day 1 through study completion (Day 95)
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Safety and tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.03
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From Day 1 through study completion (Day 95)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 19, 2018
Primary Completion (ACTUAL)
March 13, 2019
Study Completion (ACTUAL)
March 13, 2019
Study Registration Dates
First Submitted
December 28, 2017
First Submitted That Met QC Criteria
January 3, 2018
First Posted (ACTUAL)
January 4, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAMSON-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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