Harbour BioMed, a global biopharmaceutical company focused on advancing innovative antibody-based therapies in immunology and immune-oncology, has announced the online publication of results from the first-in-human Phase I clinical trial (NCT05790694/CTR20221961) of HBM9378 (also referred to as SKB378 or WIN378).
The study, led by Dr. Min Xu, a respiratory medicine specialist at Chengdu Fifth People’s Hospital, appears in the peer-reviewed journal Drug Design, Development and Therapy. Findings from the trial highlight a strong safety profile and a prolonged half-life, supporting continued investigation of HBM9378 in patients with serious immune-related conditions.
HBM9378 is a fully human monoclonal antibody with an extended half-life that targets thymic stromal lymphopoietin (TSLP). It is being co-developed by Harbour BioMed and Kelun-Biotech. The randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study enrolled 50 healthy adults to assess safety, tolerability, pharmacokinetics (PK), and immunogenicity. Participants were divided into five dose groups—20 mg, 60 mg, 200 mg, 600 mg, and 900 mg—with each cohort consisting of ten individuals, eight receiving HBM9378 and two receiving a placebo.
Results showed that treatment-emergent adverse events (TEAEs) occurred at similar rates across both the treatment and placebo groups, with no evidence of increased safety concerns at higher doses. The median time to reach peak concentration (Tmax) ranged between 4.05 and 14.1 days, while the average half-life (T1/2) was between 55.0 and 65.8 days. Drug exposure, measured by Cmax and AUC, rose proportionally with increasing doses from 20 mg to 900 mg. Anti-drug antibodies (ADA) were detected in 5% of participants (2 out of 40), with no observed clinical effects or impact on drug exposure. Notably, no injection site reactions were reported in any group.
Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, described the Phase I results as an important step forward in developing new treatments for immune-related diseases. He emphasized that the favorable safety profile and extended half-life strengthen confidence in the drug’s potential to address unmet needs in conditions such as severe asthma and chronic obstructive pulmonary disease (COPD).
Dr. Min Xu, Principal Investigator of the study, noted that HBM9378 was well-tolerated and demonstrated a promising pharmacokinetic profile in healthy volunteers. He added that its long half-life could allow for less frequent dosing, which may improve patient adherence and overall treatment outcomes. The findings pave the way for further clinical trials to evaluate the drug’s effectiveness in individuals with severe immunological disorders.
The study, led by Dr. Min Xu, a respiratory medicine specialist at Chengdu Fifth People’s Hospital, appears in the peer-reviewed journal Drug Design, Development and Therapy. Findings from the trial highlight a strong safety profile and a prolonged half-life, supporting continued investigation of HBM9378 in patients with serious immune-related conditions.
HBM9378 is a fully human monoclonal antibody with an extended half-life that targets thymic stromal lymphopoietin (TSLP). It is being co-developed by Harbour BioMed and Kelun-Biotech. The randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study enrolled 50 healthy adults to assess safety, tolerability, pharmacokinetics (PK), and immunogenicity. Participants were divided into five dose groups—20 mg, 60 mg, 200 mg, 600 mg, and 900 mg—with each cohort consisting of ten individuals, eight receiving HBM9378 and two receiving a placebo.
Results showed that treatment-emergent adverse events (TEAEs) occurred at similar rates across both the treatment and placebo groups, with no evidence of increased safety concerns at higher doses. The median time to reach peak concentration (Tmax) ranged between 4.05 and 14.1 days, while the average half-life (T1/2) was between 55.0 and 65.8 days. Drug exposure, measured by Cmax and AUC, rose proportionally with increasing doses from 20 mg to 900 mg. Anti-drug antibodies (ADA) were detected in 5% of participants (2 out of 40), with no observed clinical effects or impact on drug exposure. Notably, no injection site reactions were reported in any group.
Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, described the Phase I results as an important step forward in developing new treatments for immune-related diseases. He emphasized that the favorable safety profile and extended half-life strengthen confidence in the drug’s potential to address unmet needs in conditions such as severe asthma and chronic obstructive pulmonary disease (COPD).
Dr. Min Xu, Principal Investigator of the study, noted that HBM9378 was well-tolerated and demonstrated a promising pharmacokinetic profile in healthy volunteers. He added that its long half-life could allow for less frequent dosing, which may improve patient adherence and overall treatment outcomes. The findings pave the way for further clinical trials to evaluate the drug’s effectiveness in individuals with severe immunological disorders.
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