Healthy VolunteersPhase 1NCT03390673
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
A Phase 1 study testing HD204 and Avastin in people with Healthy Volunteers, run by Prestige Biopharma Limited at 2 sites in New Zealand.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HD204 and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 19 Sep 2018to 13 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Clinical Studies
Auckland, 1010
Christchurch Clinical Studies Trust Ltd
Christchurch, 8011
About this study
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
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..
Read the 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
- Being tested
- HD204, Avastin
- Keywords
- randomized, double-blind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD204Drug
Also called Bevacizumab
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
AvastinDrug
Also called Bevacizumab
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| HD204 | Experimental | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion Receives: Drug: HD204 |
| EU-licensed Avastin | Active comparator | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion Receives: Drug: Avastin |
| US-licensed Avastin | Active comparator | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bevacizumab PK Parameter (AUC0-inf)
PK blood samples were collected from subjects to determine the AUC0-inf of bevacizumab. Samples were collected from 0 (pre-dose) to 1680 (post-dose) on days 1-74.
Measured: 71 Days
Serum Concentration of Bevacizumab (AUC0-last)
PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.
Measured: 71 days
Serum Concentration of Bevacizumab (Cmax)
PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.
Measured: 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start19 Sep 2018
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prestige Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390673
- Sponsor's protocol ID
- SAMSON-1
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2017
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34555031
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03390673
- Acronym / sponsor ID
- SAMSON-1
- Conditions
- Healthy Volunteers
- Keywords
- randomized, double-blind
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Prestige Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HD204 | Experimental | Drug: HD204Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
| EU-licensed Avastin | Active comparator | Drug: AvastinBevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
| US-licensed Avastin | Active comparator | Drug: AvastinBevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD204Also: BevacizumabSingle-Dose 1mg/kg body weight by 90 minute intravenous infusion | Drug | HD204 |
| AvastinAlso: BevacizumabSingle-Dose 1mg/kg body weight by 90 minute intravenous infusion | Drug | EU-licensed Avastin, US-licensed Avastin |
Primary outcome
Bevacizumab PK Parameter (AUC0-inf)
Time frame: 71 Days
PK blood samples were collected from subjects to determine the AUC0-inf of bevacizumab. Samples were collected from 0 (pre-dose) to 1680 (post-dose) on days 1-74.
Serum Concentration of Bevacizumab (AUC0-last)
Time frame: 71 days
PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.
Serum Concentration of Bevacizumab (Cmax)
Time frame: 71 days
PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34555031Demarchi 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.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HD204 and Avastin in people with Healthy Volunteers, run by Prestige Biopharma Limited at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bevacizumab PK Parameter (AUC0-inf) (time frame: 71 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.