A clinical trial to compare the rate of blood clearance and safety of a biosimilar, to the original Herceptin drug, in healthy male volunteers.

INTERVENTION: A single IV infusion dose at 6 mg/kg over less than or equal to 90 minutes will be compared for the Herceptin biosimilar (NeuCeptin), EU sourced Herceptin and US sourced Herceptin. The Herceptin biosimilar is the intervention. CONDITION: Her2 positive breast cancer Her2 positive gastric cancer PRIMARY OUTCOME: To assess if NeuCeptin administered intravenously (IV) to healthy adult male subjects is comparable to Herceptin® (EU and/or US) in area under the concentration‐time curve (AUC) from time 0 to last quantifiable concentration (AUC0‐last), AUC from time 0 extrapolated to infinity (AUC0‐8), and maximum plasma concentration (Cmax) (ie, within 80.00% to 125.00% for all 3 pairwise comparisons), up to 71 days post treatment. SECONDARY OUTCOME: To assess the safety and tolerability of NeuCeptin administered as a single dose in healthy male adult subjects through 71 days post treatment, compared to Herceptin®.(EU and/or US). ; • Safety and tolerability of NeuCeptin will be compared to Herceptin‐EU and Herceptin US based on occurrence, severity, timing, and relatedness of the following until 71 days post treatment: ; ‐ Infusion‐related reactions (IRR) (local and systemic), ; ‐ Treatment‐emergent adverse events (TEAEs) and serious adverse events (SAEs), ; ‐ Clinically significant hematological and biochemical measurements (including C‐reactive protein). ; • Monitoring of vital signs and heart function – electrocardiogram (ECG) and echocardiography (LVEF) assessments, until 71 days post treatment. ; INCLUSION CRITERIA: 1. Healthy male subjects 18 to 45 years of age, inclusive. 2. Body mass index of 17.5 to 30.5 kg/m2. 3. Total body weight >50 kg and <100 kg. 4. A left ventricular ejection fraction (LVEF) within the normal range as measured by an echocardiogram within 8 weeks of randomization and diastolic function within the normal range. 5. Subjects must provide a voluntary written informed consent to participate in the study and be capable of comprehending and complying with study requirements and procedures, able and willing to complete a subject diary, return for all scheduled follow‐up visits, have expressed availability for the required study period, and access to a means of telephone contact, either residential land line or mobile. 6. Males with female partners of childbearing potential must agree to practice abstinence or double‐method, defined as condom for males and highly effective method of contraception (with <1% failure rate) for female partners f