Comparing a single 600 mg under-the-skin HER2 antibody injection: Bmab3000 versus Herceptin Hylecta in healthy men

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 trial will test whether a single 600 mg subcutaneous injection of Bmab3000 gives similar blood levels, immune reactions, safety, and tolerability to Herceptin Hylecta in healthy men.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Biocon Limited (Industry-sponsored)
• Drugs / interventions: trastuzumab
• Locations: 1 site (Christchurch, Main Building: 264 Antigua Street,)
• Trial ID: NCT07299955 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, two-arm Phase 1 trial enrolling 150 healthy male volunteers to compare the pharmacokinetics, immunogenicity, safety, and tolerability of a single 600 mg subcutaneous dose of Bmab3000 versus Herceptin Hylecta. Participants are randomized 1:1 with stratification by baseline body weight and will undergo a 3-night inpatient stay for intensive monitoring followed by approximately four months of outpatient follow-up with scheduled visits and blood sampling. Primary measurements are serial blood levels for PK, anti-drug antibody testing for immunogenicity, and standard safety assessments including vital signs, ECG, and injection-site checks. The study aims to determine whether the test product matches the reference product in these key early-phase endpoints in healthy volunteers.

Who should consider this trial

Good fit: Healthy male volunteers aged 18–65 years, weighing 50–100 kg with BMI 18.5–30 kg/m2, LVEF ≥55%, willing to use contraception and to stop or avoid disallowed medications as specified are the ideal candidates.

Not a fit: Women, people with active cancer or significant cardiac or other medical conditions, and anyone seeking direct therapeutic benefit should not expect clinical benefit from participating in this healthy-volunteer pharmacokinetic trial.

Why it matters

Potential benefit: If the products match, patients with HER2-positive cancers could gain an equivalent biosimilar option that may increase access and reduce treatment cost.

How similar studies have performed: Previous phase 1 PK and immunogenicity comparisons of trastuzumab biosimilars versus reference trastuzumab products have generally shown comparable results and supported biosimilar development.

Eligibility criteria

Inclusion Criteria:

1. Healthy male volunteers aged between 18 to 65 years; both inclusive.
2. Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
3. Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
4. 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.
5. All non-prescription medications must have been discontinued at least 14 days prior to dosing.
6. All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
7. Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
8. Willing and able to sign the informed consent form (ICF).

Exclusion Criteria:

1. History of previous exposure to trastuzumab.
2. Presence of clinically significant medical history and clinically significant findings in the physical examination.
3. Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
4. Sick sinus syndrome or known long QT syndrome (QTcF \>450 msec).
5. Pronounced sinus bradycardia (\<40 bpm), even if elicited by sport.
6. History of relevant drug and/or food allergies.
7. Positive urine drug and breath alcohol screen.
8. Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
9. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
10. Donation or loss of blood prior to drug administration.

Where this trial is running

Christchurch, Main Building: 264 Antigua Street,

• New Zealand Clinical Research (NZCR) — Christchurch, Main Building: 264 Antigua Street,, New Zealand (Recruiting)

Study contacts

• Principal investigator: Dr Cory Sellwood, MBBS — New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
• Study coordinator: Dr Gursharan Singh, MBBS, PhD

Conditions Healthy Male Participants