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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBM9378 (SKB378) Injection | Experimental | Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously |
|
| Placebo | Placebo Comparator | Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBM9378 (SKB378) Injection | Drug | Strength: 225 mg (1.5 mL)/vial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | 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 | Strat of Treatment to end of study (approsimately 160days) |
| Pharmacokinetics-Tmax | Time to Cmax of HBM9378 | Strat of Treatment to end of study (approsimately 160days) |
| Pharmacokinetics-Cmax | Maximum observed concentration of HBM9378 | Strat of Treatment to end of study (approsimately 160days) |
| Pharmacokinetics-CL/F | Apparent clearance of HBM9378 | Strat of Treatment to end of study (approsimately 160days) |
| Pharmacokinetics-Vd/F | Apparent volume of distribution during terminal phase of HBM9378 | Strat of Treatment to end of study (approsimately 160days) |
| Pharmacokinetics-T1/2 | Terminal elimination half-life of HBM9378 | Strat of Treatment to end of study (approsimately 160days) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The percentage of patients with anti-drug antibodies after administration. | Strat of Treatment to end of study (approsimately 160days) |
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Inclusion Criteria:
Exclusion Criteria:
History of relevant allergy/hypersensitivity.
History of any of the following diseases:
Subject who are currently suffering from any medical condition.
Subjects who have undergone organ transplantation.
Received immunosuppressive therapy within 6 months prior to randomization.
Received any biological product within 90 days or 5 half-lives (for other study drugs), whichever is longer, prior to randomization, or participated in another clinical study and received a study drug.
Received any drug within 4 weeks prior to randomization.
Subjects who had an immunization within 4 weeks prior to randomization; subjects who are scheduled to have an immunization during the study or within 4 weeks after the end of study.
Donated or lost 400 mL or more blood, or received transfusion of blood or any blood product within 60 days prior to randomization.
Subjects who are smokers or have used tobacco or nicotine-containing products within 3 months prior to randomization.
Subjects who regularly consumed alcohol within 3 months prior to screening, or who had consumed alcohol after screening and before administration.
Subjects who had been exposed to a tuberculosis (TB) patient within 6 months prior to randomization.
Subjects who had drug abuse or a positive urine drug screen within 12 months prior to randomization.
Pregnant or lactating women.
Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test result, or clinically significantly abnormal syphilis serology test result.
History of immunodeficiency disease, including clinically significantly abnormal HIV antibody test result.
Clinically significantly abnormal vital signs, physical examination, chest radiography, electrocardiogram , or laboratory tests , as judged by the investigator.
In the investigator's judgment, may increase the risk to the subject.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth People's Hospital of Chengdu | Sichuan | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41873335 | Derived | Yang X, Xu M, Cao N, Zhao S, Wei Y, Lu J, Luo R, Ge J, Tao X, He W. Safety, Tolerability, and Pharmacokinetics of HBM9378 (SKB378/WIN378), a Fully Human IgG1 Monoclonal Antibody Against TSLP After Single Ascending Doses in Chinese Healthy Subjects. Drug Des Devel Ther. 2026 Mar 18;20:538649. doi: 10.2147/DDDT.S538649. eCollection 2026. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo |
| Drug |
Strength: 225 mg (1.5 mL)/vial |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |