eligibility_summary
Consented adults 18–60, BMI 18–32. Exclude: significant disease, arrhythmia/abnormal ECG, QTcF >450 M/>470 F, SBP ≥140/≤90, DBP ≥90/≤50, pulse ≥100/≤40, allergy (seasonal OK), eGFR <70, ALT/AST >1.5×ULN, HBV/HCV/HIV positive (HBV immunity/prior infection OK), live vaccine 5 wks prior/90 d post (inactive/COVID OK), latent TB or recent/active infection, most meds/supplements ≤30 d/5 half-lives (acetaminophen, contraception/HRT allowed), investigational drug ≤90 d/5 half-lives, prior rocatinlimab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Rocatinlimab (AMG 451) delivered as a single subcutaneous dose via either an autoinjector or a vial, both arms test the same drug to compare relative bioavailability in healthy adults. Type and mechanism: Rocatinlimab is a human IgG1 monoclonal antibody targeting OX40 (CD134), a TNFR family costimulatory receptor on activated T cells. It blocks OX40–OX40L signaling and can deplete OX40+ T cells via ADCC, reducing T‑cell survival and pathogenic activation. Cells/pathways targeted: Activated CD4+ T cells (especially Th2 memory/effector cells), the OX40/TNFRSF4 costimulatory pathway, downstream type 2 inflammation (e.g., IL‑4/IL‑13/IL‑5 axes) implicated in atopic dermatitis.