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Asthma drug HBM9378 passes first safety check in healthy people

NCT ID NCT05790694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a single injection of HBM9378 in 50 healthy Chinese adults to see if it is safe and how the body processes it. The goal was not to treat asthma but to gather safety and drug-level data. Participants were healthy, not asthma patients, so no direct benefit was expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Fifth People's Hospital of Chengdu

    Sichuan, Chengdu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.