Harbour BioMed has announced the publication of results from its first-in-human Phase I clinical trial of HBM9378, a novel monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in the peer-reviewed journal Drug Design, Development and Therapy.

The study, led by Min Xu at Chengdu Fifth People's Hospital, evaluated the safety, tolerability, pharmacokinetics and immunogenicity of HBM9378 in healthy adult volunteers.

HBM9378, also known as SKB378 or WIN378, is a fully human monoclonal antibody with an extended half-life, jointly developed by Harbour BioMed and Kelun-Biotech. The therapy is being explored for the treatment of severe immunological conditions, including asthma and Chronic Obstructive Pulmonary Disease.

The randomised, double-blind, placebo-controlled, single-ascending-dose study enrolled 50 healthy participants across five dose cohorts ranging from 20 mg to 900 mg. Each cohort included eight participants receiving HBM9378 and two receiving placebo.

Results demonstrated that the incidence of treatment-emergent adverse events was comparable between the treatment and placebo groups, with no dose-related increase in safety risks. The therapy showed a prolonged half-life ranging from 55 to 65.8 days, indicating potential for reduced dosing frequency in future clinical use.

Pharmacokinetic analysis revealed dose-proportional increases in drug exposure, while the incidence of anti-drug antibodies remained low and did not impact drug performance. No injection site reactions were reported across any dose group.

The favourable safety profile and extended half-life observed in the study support further clinical development of HBM9378 in patients with severe immunological disorders.

The company noted that these findings mark an important step in advancing its pipeline of antibody-based therapies aimed at addressing unmet medical needs in immunology and immune-oncology.