A Phase 1 interventional study of HBM9378 (SKB378) Injection and Placebo in Asthma, sponsored by Harbour BioMed (Guangzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Harbour BioMed (Guangzhou) Co. Ltd. · Phase 1, Interventional, and Treatment
The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive HBM9378 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 50 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Harbour BioMed (Guangzhou) Co. Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of any of the following diseases:
Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously
Drug: HBM9378 (SKB378) Injection
Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously
Drug: Placebo
Strength: 225 mg (1.5 mL)/vial
Strength: 225 mg (1.5 mL)/vial
Adverse events
Incidence and severity of adverse events
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HBM9378 administration
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Tmax
Time to Cmax of HBM9378
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Cmax
Maximum observed concentration of HBM9378
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-CL/F
Apparent clearance of HBM9378
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Vd/F
Apparent volume of distribution during terminal phase of HBM9378
Time frame: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-T1/2
Terminal elimination half-life of HBM9378
Time frame: Strat of Treatment to end of study (approsimately 160days)
Immunogenicity
The percentage of patients with anti-drug antibodies after administration.
Time frame: Strat of Treatment to end of study (approsimately 160days)
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Harbour BioMed (Guangzhou) Co. Ltd.