eligibility_summary
Eligible: Healthy males 18–50, 65–90 kg, BMI 18–28, consent, contraception during study + 6 mo. Exclude: serious disease or infection <1 mo, immune disease, herpes zoster (recent single <6 mo or multi-dermatomal/CNS ever), + indirect Coombs, biologics/cell therapy/anti‑CD38 <6 mo, meds <2 wks, allergies, blood loss ≥200 mL <3 mo, trials <3 mo (or 5 t½) or surgery <3 mo, HBV/HCV/HIV/TP+, drug abuse, recent vax (live/vector <12 mo or planned post, others <1 mo), investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1 PK/safety similarity study in healthy adults comparing QL2109 vs DARZALEX FASPRO (SC, single 1800 mg dose). Drugs and mechanisms: • QL2109: investigational subcutaneous anti‑CD38 monoclonal antibody, expected to mirror daratumumab’s mechanism (IgG1 mAb). • DARZALEX FASPRO (daratumumab and hyaluronidase‑fihj): subcutaneous anti‑CD38 human IgG1κ mAb plus recombinant human hyaluronidase (rHuPH20) to facilitate SC absorption by transiently degrading hyaluronan. Cells/pathways targeted: • Primary target: CD38 on plasma cells/myeloma cells. • Effector mechanisms: complement‑dependent cytotoxicity (CDC), antibody‑dependent cellular cytotoxicity (ADCC), antibody‑dependent cellular phagocytosis (ADCP), and apoptosis via Fc cross‑linking. • Immune modulation: depletion of CD38+ immunosuppressive cells (Tregs, Bregs, MDSCs), enhancing T/NK‑cell activity. • rHuPH20 targets hyaluronan in the SC matrix (delivery aid).