AsthmaPhase 1NCT05790694
A Trial of HBM9378 in Healthy Chinese Subjects
A Phase 1 study testing HBM9378 (SKB378) Injection in people with Asthma, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- HBM9378 (SKB378) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2022to 24 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Study in Healthy Chinese Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HBM9378 (SKB378) After Subcutaneous Administration.
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.
- Conditions
- Asthma
- Being tested
- HBM9378 (SKB378) Injection, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM9378 (SKB378) InjectionDrug
Strength: 225 mg (1.5 mL)/vial
PlaceboDrug
Strength: 225 mg (1.5 mL)/vial
| Study group | Role | What they receive |
|---|---|---|
| HBM9378 (SKB378) Injection | Experimental | Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously Receives: Drug: HBM9378 (SKB378) Injection |
| Placebo | Placebo comparator | Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of adverse events
Measured: 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
Measured: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Tmax
Time to Cmax of HBM9378
Measured: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Cmax
Maximum observed concentration of HBM9378
Measured: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-CL/F
Apparent clearance of HBM9378
Measured: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-Vd/F
Apparent volume of distribution during terminal phase of HBM9378
Measured: Strat of Treatment to end of study (approsimately 160days)
Pharmacokinetics-T1/2
Terminal elimination half-life of HBM9378
Measured: Strat of Treatment to end of study (approsimately 160days)
Secondary outcomes (1)
Immunogenicity
The percentage of patients with anti-drug antibodies after administration.
Measured: Strat of Treatment to end of study (approsimately 160days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start23 Sep 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790694
- Sponsor's protocol ID
- 9378.1
- Status last verified
- Oct 2023
- First submitted
- 27 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Study in Healthy Chinese Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HBM9378 (SKB378) After Subcutaneous Administration.
- ClinicalTrials.gov ID
- NCT05790694
- Acronym / sponsor ID
- 9378.1
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBM9378 (SKB378) Injection | Experimental | Drug: HBM9378 (SKB378) InjectionDose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously |
| Placebo | Placebo comparator | Drug: PlaceboDose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM9378 (SKB378) InjectionStrength: 225 mg (1.5 mL)/vial | Drug | HBM9378 (SKB378) Injection |
| PlaceboStrength: 225 mg (1.5 mL)/vial | Drug | Placebo |
Primary outcome
Adverse events
Time frame: Strat of Treatment to end of study (approsimately 160days)
Incidence and severity of adverse events
Pharmacokinetics-AUC0-last
Time frame: Strat of Treatment to end of study (approsimately 160days)
Area under the concentration-time curve from time 0 to last time point after HBM9378 administration
Pharmacokinetics-Tmax
Time frame: Strat of Treatment to end of study (approsimately 160days)
Time to Cmax of HBM9378
Pharmacokinetics-Cmax
Time frame: Strat of Treatment to end of study (approsimately 160days)
Maximum observed concentration of HBM9378
Pharmacokinetics-CL/F
Time frame: Strat of Treatment to end of study (approsimately 160days)
Apparent clearance of HBM9378
Pharmacokinetics-Vd/F
Time frame: Strat of Treatment to end of study (approsimately 160days)
Apparent volume of distribution during terminal phase of HBM9378
Pharmacokinetics-T1/2
Time frame: Strat of Treatment to end of study (approsimately 160days)
Terminal elimination half-life of HBM9378
1 secondary outcome
Immunogenicity
Time frame: Strat of Treatment to end of study (approsimately 160days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41873335Yang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBM9378 (SKB378) Injection in people with Asthma, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Strat of Treatment to end of study (approsimately 160days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.