eligibility_summary
Eligibility: Healthy adult males 18-55, BMI 18.5-30.0 and ≥50 kg, non-smokers/tobacco-free ≥1 yr, able to consent/comply, if married, agree to contraception or spouse nonchildbearing. Exclude: significant disease or abnormal screening (incl LVEF<55%), cardiac history, neutropenia, Hep B/C+, cancer, hematopoietic growth factors/monoclonal antibodies/immunoglobulins in past 6 mo, live vaccine within 30 d or needed during study, drug abuse, alcoholism, or moderate alcohol use.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 randomized, double-blind, parallel study in healthy adult males comparing Incepta’s trastuzumab (proposed biosimilar) vs Roche’s Herclon after a single 6 mg/kg IV dose, assessing PK, immunogenicity, and safety. Drug/intervention: Trastuzumab, a humanized IgG1 kappa monoclonal antibody (biologic), anti-HER2/ErbB2. Mechanisms: binds the HER2 extracellular domain to block receptor dimerization and signaling, suppressing proliferation/survival pathways, engages Fc-mediated immune effector functions (ADCC). Targets: HER2-overexpressing epithelial tumor cells, HER2 signaling axis (e.g., PI3K/AKT, MAPK), immune effector cells (e.g., NK cells via Fcγ receptors).