A Trial of HBM9378 in Healthy Chinese Subjects

NCT05790694 | Completed Phase 1

• 1 other identifier: 9378.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (7)

• 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)

Secondary Outcomes (1)

• Immunogenicity

  Strat of Treatment to end of study (approsimately 160days)

Study Arms (2)

HBM9378 (SKB378) Injection

EXPERIMENTAL

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

Drug: HBM9378 (SKB378) Injection

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HBM9378 (SKB378) Injection DRUG

Strength: 225 mg (1.5 mL)/vial

HBM9378 (SKB378) Injection

Placebo DRUG

Strength: 225 mg (1.5 mL)/vial

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of relevant allergy/hypersensitivity.
• History of any of the following diseases:
• Any clinically significant comorbidity, as judged by the investigator.
• Clinical signs of active infection found at screening.
• Previous malignancy within the past 5 years.
• Acute or chronic bronchospastic disease within the past 3 years.
• 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.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

The Fifth People's Hospital of Chengdu

Sichuan, Chengdu, China

Location

Related Publications (1)

• 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.

  PMID: 41873335 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Injections

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 30, 2023
• Study Start: September 23, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: May 1, 2026

Record last verified: 2023-10

Locations

CN (1)