Healthy Volunteers Clinical Trial
Official title:
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
Verified date | February 2023 |
Source | Prestige Biopharma Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 119 |
Est. completion date | March 13, 2019 |
Est. primary completion date | March 13, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
New Zealand | Auckland Clinical Studies | Auckland | |
New Zealand | Christchurch Clinical Studies Trust Ltd | Christchurch |
Lead Sponsor | Collaborator |
---|---|
Prestige Biopharma Limited |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Immunogenicity | Incidence of anti-bevacizumab antibodies | Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment) | |
Secondary | Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) | Safety and tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.03 | From Day 1 through study completion (Day 95) |
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