eligibility_summary
Include: Healthy men 18–45, BMI 18.5–30, consent, barrier contraception + partner spermicide/IUD during study + 6 mo, screening normal, HIV/syph/HBV/HCV neg, LVEF ≥60, drug/alcohol screens neg. Exclude: allergy/hypersensitivity (incl pertuzumab/mAbs), vaccine <30 d, infection <4 w, recent meds, abnormal vitals/labs, major disease/cancer, GI surgery (≠ appendectomy), >4 URIs/6 mo, <3 mo blood donation/trial, alcohol >10/wk, smoking >10/d, diet/lifestyle issues, psych/adherence issues, poor veins.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Pertuzumab (Mabscale biosimilar) vs Perjeta (reference pertuzumab), both are recombinant humanized IgG1 monoclonal antibodies given i.v. Mechanism: bind HER2/ERBB2 extracellular domain (subdomain II) to block ligand-induced heterodimerization with EGFR/HER3/HER4, inhibiting downstream PI3K/AKT and MAPK/ERK signaling and reducing cell proliferation/survival, also engage Fcγ receptors to mediate ADCC by immune effectors (e.g., NK cells). Targets: HER2-overexpressing epithelial/tumor cells, pathways—HER2 dimerization/activation and downstream proliferation/survival cascades, immune effector ADCC pathway. Trial goal: PK/immunogenicity/safety equivalence in healthy men (single 420 mg IV).