eligibility_summary
Men 18–50, 50–80 kg, BMI 19–28, healthy, consent given, no pregnancy/sperm donation, effective contraception through 6 months. Exclude: significant disease/recent infection, immune disorder, shingles recent/recurrent, chronic diarrhea/enteritis, +IAT, prior mAbs/cell therapy or CD38 drugs, meds ≤2 wks, multiple allergies, venipuncture issues, recent blood loss/other trial/surgery, HBV/HCV/HIV/syphilis+, smokers >5/day or cant abstain, live/vector vaccines ≤12 mo or planned, other vaccines ≤1 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Felzartamab (TJ202/MOR202), a human IgG1 monoclonal antibody targeting CD38. Two formulations compared for PK: T (manufactured by I‑Mab Biopharma, Hangzhou) and R (manufactured by Patheon Italia), each given as a single 8 mg/kg IV dose in a randomized, double‑blind, two‑period crossover (T→R or R→T) in healthy men. Mechanism of action: Binds CD38, an ectoenzyme/receptor involved in NAD+ metabolism and calcium signaling (NADase/cADPR pathway), and depletes CD38+ cells via Fc‑mediated effector functions (ADCC, ADCP, may engage complement). Target cells/pathways: CD38‑expressing plasma cells (including long‑lived antibody‑producing cells), with effects on CD38+ NK cells, activated T and B cells, and some myeloid cells. Purpose: assess pharmacokinetic comparability, safety, tolerability, and immunogenicity of pre‑ vs post‑process drug. Type: biologic (monoclonal antibody).