Cheaper avastin copycat tested in healthy volunteers
NCT ID NCT03390673
First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 4 times
Summary
This study tested a new biosimilar drug called HD204 against the original Avastin in 119 healthy men. The goal was to see if the body processes both drugs the same way. Participants received a single dose, and researchers measured drug levels and safety. The trial is complete, but it only looked at healthy volunteers, not patients with disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bevacizumab (HD204, a biosimilar version of Avastin)
- What this could lead to
- If successful, this could show that HD204 works similarly to Avastin, potentially offering a more affordable treatment option for conditions like cancer.
- What could go wrong
- This is an early-phase trial in healthy volunteers, not patients. It only checks how the drug moves through the body, not if it treats disease. Results may not predict real-world effectiveness or safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
119 people
The number who actually took part.
- Started
-
Sep 2018
- Finished
-
Mar 2019
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Auckland Clinical Studies
Auckland, 1010, New Zealand
-
Christchurch Clinical Studies Trust Ltd
Christchurch, 8011, New Zealand
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