eligibility_summary
Eligibility: consent, adults 18–65, BMI 18–32. Exclude: significant illness, arrhythmia/ECG issues, QTcF >450 ms (men) or >470 ms (women), SBP >140 or <90, DBP >90, pulse >100, eGFR <70, ALT/AST >1.5×ULN, positive HBV/HCV/HIV, latent TB or recent unresolved systemic infection, live vaccine ≤5 wks prior or planned ≤90 days (inactive incl. COVID OK), meds within 30 d (except acetaminophen, hormones), herbs/supplements unless approved, recent investigational drug, rocatinlimab exposure.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Rocatinlimab (AMG 451) given as a single subcutaneous dose via either vial or prefilled syringe, type: humanized, afucosylated IgG1 monoclonal antibody. Mechanism of action: antagonizes the OX40 (CD134) costimulatory receptor and can deplete OX40+ activated T cells via ADCC, thereby reducing T‑cell activation, survival, and memory and dampening type 2 inflammation relevant to atopic dermatitis. Target cells/pathways: OX40–OX40L pathway on T cells/APCs, activated CD4+ T cells, especially Th2 cells, downstream reduction of type‑2 cytokines (e.g., IL‑4, IL‑13, IL‑31). Study: Phase 1, open-label, randomized, parallel-group in healthy adults to assess relative bioavailability/PK and safety of vial vs prefilled syringe.