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CompletedNCT05790694Updated May 1, 2026

A Trial of HBM9378 in Healthy Chinese Subjects

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2022, registered Feb 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Written informed consent must be obtained.
  2. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities.
  3. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive).
  4. Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ;
  5. Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study.
  6. Can communicate successfully with the investigator and understand and comply with the requirements of this study.

Exclusion criteria

Exclusion Criteria:

  1. History of relevant allergy/hypersensitivity.
  2. History of any of the following diseases:

    1. Any clinically significant comorbidity, as judged by the investigator.
    2. Clinical signs of active infection found at screening.
    3. Previous malignancy within the past 5 years.
    4. Acute or chronic bronchospastic disease within the past 3 years.
  3. Subject who are currently suffering from any medical condition.
  4. Subjects who have undergone organ transplantation.
  5. Received immunosuppressive therapy within 6 months prior to randomization.
  6. 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.
  7. Received any drug within 4 weeks prior to randomization.
  8. 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.
  9. Donated or lost 400 mL or more blood, or received transfusion of blood or any blood product within 60 days prior to randomization.
  10. Subjects who are smokers or have used tobacco or nicotine-containing products within 3 months prior to randomization.
  11. Subjects who regularly consumed alcohol within 3 months prior to screening, or who had consumed alcohol after screening and before administration.
  12. Subjects who had been exposed to a tuberculosis (TB) patient within 6 months prior to randomization.
  13. Subjects who had drug abuse or a positive urine drug screen within 12 months prior to randomization.
  14. Pregnant or lactating women.
  15. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test result, or clinically significantly abnormal syphilis serology test result.
  16. History of immunodeficiency disease, including clinically significantly abnormal HIV antibody test result.
  17. Clinically significantly abnormal vital signs, physical examination, chest radiography, electrocardiogram , or laboratory tests , as judged by the investigator.
  18. In the investigator's judgment, may increase the risk to the subject.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    HBM9378 (SKB378) Injection

    Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously

    Drug: HBM9378 (SKB378) Injection

  • Placebo comparator
    Placebo

    Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously

    Drug: Placebo

Interventions

  • DrugHBM9378 (SKB378) Injection

    Strength: 225 mg (1.5 mL)/vial

  • DrugPlacebo

    Strength: 225 mg (1.5 mL)/vial

06

What researchers measure

Primary outcomes

  1. Adverse events

    Incidence and severity of adverse events

    Time frame: Strat of Treatment to end of study (approsimately 160days)

  2. 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)

  3. Pharmacokinetics-Tmax

    Time to Cmax of HBM9378

    Time frame: Strat of Treatment to end of study (approsimately 160days)

  4. Pharmacokinetics-Cmax

    Maximum observed concentration of HBM9378

    Time frame: Strat of Treatment to end of study (approsimately 160days)

  5. Pharmacokinetics-CL/F

    Apparent clearance of HBM9378

    Time frame: Strat of Treatment to end of study (approsimately 160days)

  6. Pharmacokinetics-Vd/F

    Apparent volume of distribution during terminal phase of HBM9378

    Time frame: Strat of Treatment to end of study (approsimately 160days)

  7. Pharmacokinetics-T1/2

    Terminal elimination half-life of HBM9378

    Time frame: Strat of Treatment to end of study (approsimately 160days)

Secondary outcomes

  1. Immunogenicity

    The percentage of patients with anti-drug antibodies after administration.

    Time frame: Strat of Treatment to end of study (approsimately 160days)

07

Study locations

1 site
  • The Fifth People's Hospital of Chengdu
    Sichuan, Chengdu, China
08

References and documents

Publications

  • 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. PubMed 41873335 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05790694
Lead sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Mar 30, 2023
Start date
Sep 23, 2022
Primary completion
Oct 24, 2023
Completion
Oct 24, 2023
Last update
May 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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