- Harbour BioMed reported online publication of first-in-human Phase I results from a randomized, double-blind, placebo-controlled single-ascending-dose trial of HBM9378 (SKB378/WIN378), a TSLP-targeting monoclonal antibody.
- The study enrolled 50 healthy adults across five cohorts (20 mg to 900 mg), with eight participants receiving HBM9378 and two receiving placebo in each cohort.
- Treatment-emergent adverse events were reported as comparable between HBM9378 dose groups and placebo, and no injection site reactions were observed.
- Pharmacokinetic results included a median Tmax range of 4.05 to 14.1 days and a mean half-life range of 55 to 65.8 days.
- Anti-drug antibodies were reported in 5% (2/40) of participants who received HBM9378, with no clinical correlate or impact on drug exposure.
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