NCT07299955 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
| NCT ID | NCT07299955 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Biocon Biologics UK PLC |
| Condition | Healthy Male Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2026-02-28 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Dr Cory Sellwood, MBBS
PRINCIPAL INVESTIGATOR
New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
Frequently Asked Questions
Who can join the NCT07299955 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying Healthy Male Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07299955 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07299955 currently recruiting?
Yes, NCT07299955 is actively recruiting participants. Contact the research team at gursharan.singh@biocon.com for enrollment information.
Where is the NCT07299955 trial being conducted?
This trial is being conducted at Christchurch, New Zealand.
Who is sponsoring the NCT07299955 clinical trial?
NCT07299955 is sponsored by Biocon Biologics UK PLC. The principal investigator is Dr Cory Sellwood, MBBS at New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand. The trial plans to enroll 150 participants.