eligibility_summary
Eligibility: Healthy adults 18–65 who consent, comply, PI‑judged healthy. WOCBP/men must use effective contraception, men no sperm donation through Day 76. Key exclusions: poor venous access, BMI <18.5 or ≥35, abnormal vitals/ECG, significant GI/hepatic/renal/cardiovascular disease, diabetes/pancreatitis, infection, abnormal labs, HIV/HBV/HCV, drug/alcohol use or positive screens, pregnancy/nursing, recent new meds, vaccines, other trials, blood/plasma donation, inability to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: TRL345, a fully human IgG1κ monoclonal antibody, given IV (1 or 10 mg/kg) vs placebo. Mechanism of action: TRL345 binds the conserved AD‑2 site I epitope on human cytomegalovirus (HCMV) glycoprotein B (gB), neutralizing virus by blocking gB‑mediated attachment/fusion and cell‑to‑cell spread. As an IgG1, it may also engage Fc‑mediated effector functions (ADCC and complement) to enhance clearance. Targeted cells/pathways: Viral entry pathway via HCMV gB on virions and infected cells, downstream engagement of Fcγ receptor–bearing innate immune cells (e.g., NK cells, macrophages) and complement pathways. Purpose: First‑in‑human safety, PK/PD, and ex vivo concentration‑dependent antiviral activity to guide dosing for future studies in transplant and maternal–fetal settings. Status: Phase 1, double‑blind, single ascending dose in healthy adults.