eligibility_summary
Eligible: males 18–60, BMI 18.5–<28, weight ≥55 kg, healthy on screening, consented. Exclude: clinically significant disease, infection <1 mo, immune disease, recent (≤6 mo), multi-dermatomal, or CNS zoster, positive indirect Coombs, mAbs/cell therapy <6 mo or prior CD38 agents, any meds <2 wks, serious allergies, needle phobia, blood loss ≥200 mL <3 mo, other trials/major surgery <3 mo, HBV/HCV/HIV/TP+, drug abuse, live/vector vaccines <12 mo before/after or others <1 mo, noncompliant contraception, other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05679258 (Phase I, randomized, parallel). In healthy Chinese males, single 8 mg/kg IV doses compared HLX15 with daratumumab (DARZALEX) sourced from US/CN/EU to assess PK, safety, tolerability, and immunogenicity. Drugs/Mechanisms: - HLX15: recombinant anti-CD38 fully human monoclonal antibody (immunotherapy). - Daratumumab: anti-CD38 monoclonal antibody (reference product). Both bind CD38 and eliminate CD38+ cells primarily via immune effector mechanisms—antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis, may also induce apoptosis and modulate CD38 enzymatic signaling. Targets: CD38 on malignant plasma cells in multiple myeloma and CD38+ immune cells (e.g., plasma cells, activated B/T cells, NK cells, some myeloid cells).