LB793: A Phase 1, Open-Label, Single Ascending Dose Study in Healthy Subjects of the Safety, Tolerability and Pharmacokinetics of ASLAN004, a Novel IgG Anti-IL-13 Receptor Alpha 1 Inhibitor

The phase 1 study evaluated the safety, tolerability, and pharmacokinetics of ASLAN004, a novel IgG4 anti-IL-13 receptor alpha 1 monoclonal antibody, in healthy male subjects. The study involved two parts: intravenous administration in 5 ascending dose cohorts (0.1 to 10 mg/kg) and subcutaneous administration in 4 cohorts (75 to 150 mg). ASLAN004 was well tolerated with no serious adverse events, and only mild itch at the injection site was reported in one case. Pharmacokinetic analysis showed peak serum concentrations 2–4 hours post-intravenous and approximately 4 days post-subcutaneous administration. The pharmacodynamic effect increased with dose, and subcutaneous administration showed more variation in effects compared to intravenous. The study's findings supported further development of ASLAN004 as a potential therapy for atopic dermatitis, asthma, and related diseases.