Healthy Male ParticipantsPhase 1NCT07299955
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers
A Phase 1 study testing Bmab3000 and Herceptin Hylecta® in people with Healthy Male Participants, run by Biocon Biologics UK PLC at 1 site in New Zealand.
Trial summary
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Participants
- What is being tested?
- Bmab3000 and Herceptin Hylecta®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Feb 2026to 9 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
- All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
- Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
- Willing and able to sign the informed consent form (ICF).
Who cannot join
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
- History of relevant drug and/or food allergies.
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- Positive urine drug and breath alcohol screen.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Donation or loss of blood prior to drug administration.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research (NZCR)
Christchurch, Main Building: 264 Antigua Street,
About this study
Official title: A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
Read the detailed description
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic \& immunogenicity analyses and final laboratory evaluations.
- Conditions
- Healthy Male Participants
- Being tested
- Bmab3000, Herceptin Hylecta®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmab3000Biological
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL
Herceptin Hylecta®Biological
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL
| Study group | Role | What they receive |
|---|---|---|
| Bmab3000 | Experimental | Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL Receives: Biological: Herceptin Hylecta® |
| Herceptin Hylecta® | Active comparator | Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL Receives: Biological: Bmab3000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration (Cmax) of drug Bmab 3000
Measured: Day 1 to Day 91
AUCo-∞
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: Day 1 to Day 91
Secondary outcomes (7)
AUCo-t
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification
Measured: Day 1 to Day 91
Tmax
Time to maximum observed concentration
Measured: Day 1 to Day 91
Vd/F
Volume of distribution
Measured: Day 1 to Day 91
Cl/F
drug clearance
Measured: Day 1 to Day 91
t1/2
Apparent terminal elimination half-life
Measured: Day 1 to Day 91
AUC% extrapolation
% of the AUC that has been derived after extrapolation
Measured: Day 1 to Day 91
λz
Elimination rate constant
Measured: Day 1 to Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start28 Feb 2026
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Cory Sellwood, MBBS, Principal investigator, New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New ZealandDr Leanne Barnett, MBBS, Principal investigator, New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299955
- Sponsor's protocol ID
- BIO-TRASTU-103
- Other IDs
- U1111-1329-7865
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT07299955
- Acronym / sponsor ID
- BIO-TRASTU-103
- Conditions
- Healthy Male Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Biocon Biologics UK PLCIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
Detailed description
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic \& immunogenicity analyses and final laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmab3000 | Experimental | Biological: Herceptin Hylecta®Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
| Herceptin Hylecta® | Active comparator | Biological: Bmab3000Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
Key exclusion criteria (10 listed)
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
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 |
|---|---|---|
| Bmab3000Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL | Biological | Herceptin Hylecta® |
| Herceptin Hylecta®Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL | Biological | Bmab3000 |
Primary outcome
Cmax
Time frame: Day 1 to Day 91
Maximum observed concentration (Cmax) of drug Bmab 3000
AUCo-∞
Time frame: Day 1 to Day 91
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)
7 secondary outcomes
AUCo-t
Time frame: Day 1 to Day 91
Tmax
Time frame: Day 1 to Day 91
Vd/F
Time frame: Day 1 to Day 91
Cl/F
Time frame: Day 1 to Day 91
t1/2
Time frame: Day 1 to Day 91
AUC% extrapolation
Time frame: Day 1 to Day 91
λz
Time frame: Day 1 to Day 91
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Dr Cory Sellwood, MBBS principal investigator
New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
Dr Leanne Barnett, MBBS principal investigator
New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bmab3000 and Herceptin Hylecta® in people with Healthy Male Participants, run by Biocon Biologics UK PLC at 1 site 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 8 inclusion and 10 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: Day 1 to Day 91). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026; AzTrials last refreshed its copy on 5 Nov 2026.