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.
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.
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).