eligibility_summary
Eligible: mainland China residents of Chinese ancestry, age 18-65, BMI 18-30, consented. Exclude: significant illness, active infection/recent systemic anti-infective use, immunocompromised/transplant, skin lesions, autoimmune disease, positive HBsAg/HBcAb, HCV Ab, HIV (unless immune), or positive T-spot, recent/planned live or COVID-19 vaccines, recent meds (30d/5 half-lives) except acetaminophen <=2 g/day, HRT/contraceptives, recent investigational drug, prior rocatinlimab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06214481 (Phase 1, open‑label, single‑dose) in healthy Chinese adults. Intervention: Rocatinlimab (AMG 451, KHK4083), a human afucosylated IgG1 monoclonal antibody administered subcutaneously. Mechanism of action: Targets and binds OX40 (CD134), a T‑cell co‑stimulatory receptor in the TNFR superfamily. It blocks OX40–OX40L signaling to reduce T‑cell activation/survival and mediates ADCC to deplete OX40+ activated T cells. Cells/pathways targeted: Activated effector/memory T cells (notably Th2, and also Th1/Th17 populations) implicated in atopic dermatitis, OX40–OX40L co‑stimulation axis involved in dendritic cell–T‑cell interactions and inflammatory cytokine production (e.g., IL‑4/IL‑13). Primary aim: characterize pharmacokinetics, safety, and tolerability after a single SC dose.