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

Recruiting now · Phase 1

Conditions studied: Healthy Male Participants

In brief

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.

Key facts

Study ID

NCT07299955

Run by

Biocon Biologics UK PLC

People needed

150

Starts

2026-02-28

Expected to finish

2026-06-30

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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