eligibility_summary
Eligibility: Healthy Chinese males 18–60, BMI 18.5–28, normal screening tests, LVEF >50% (echo ≤14 days), consent, and reliable contraception for 3 months or infertility. Exclude: significant diseases, biologics ≤6 mo, severe allergies, meds ≤28 d, blood donation ≤3 mo, other trials ≤3 mo, HBsAg/HCV/HIV/TP positive, drug abuse/positive screen, recent/planned surgery, recent/planned vaccination, needle/blood phobia, restrictive diets, smoking >5/day, alcohol >15 g/day or +test, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06159101: Phase I randomized, parallel, single-dose study in healthy Chinese males comparing HLX13 with Yervoy (ipilimumab, US/EU/CN-sourced). Interventions: HLX13 (Henlius), a recombinant fully human anti-CTLA-4 monoclonal antibody, ipilimumab (Yervoy), an anti-CTLA-4 monoclonal antibody. Type: immune checkpoint inhibitors delivered IV (0.3 mg/kg). Mechanism: bind CTLA-4 on activated T cells and regulatory T cells, blocking CTLA-4 interaction with CD80/CD86 on antigen-presenting cells, thereby enhancing CD28 costimulation and T-cell activation, ipilimumab may also reduce intratumoral Tregs via Fc effector functions. Targets: CTLA-4 pathway, CD4+/CD8+ T cells, Tregs, and APCs. Study compares PK, safety, tolerability, and immunogenicity.