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New shot shows promise for teen asthma

NCT ID NCT06786455

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a single injection of a new drug called SHR-1905 in 9 teenagers with asthma. The goal was to see how the drug moves through the body, if it is safe, and if it helps control asthma. Participants were aged 12 to 17, had asthma for at least 6 months, and were on stable maintenance therapy. The study measured drug levels, side effects, and changes in breathing and inflammation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 2025

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

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. The age of signing the informed consent must be ≥12 years old and \<18 years old, both male and female. 2. Body weight ≥30 kg and BMI≥18 kg/m2. 3. The clinical diagnosis was asthma for at least 6 months. 4. Subjects receiving asthma maintenance therapy were required to maintain a stable dose for 4 weeks prior to baseline. 5. FEV1/ estimated value of pre-BD before bronchodilator in screening period must be ≥40%. 6. Screening period bronchial dilation test or bronchial excitation test positive. 7. Informed consent was signed before the trial. 8. Potentially fertile subjects voluntarily take appropriate contraceptive measures. Exclusion Criteria: 1. Combined with clinically significant lung disease other than asthma 2. A combination of diseases other than asthma that may affect lung function 3. Combined with other pulmonary or systemic diseases associated with eosinophil elevation, or other diseases associated with eosinophil elevation that the investigators believe need to be excluded. 4. Bronchial thermoplasty or bronchial cryoablation were performed within 1 year prior to baseline. 5. Acute asthma attacks requiring systemic glucocorticoid use for ≥3 days occurred within 1 month prior to baseline. 6. Systemic glucocorticoids were used as maintenance therapy for the first 3 months of the baseline period. 7. Acute episodes of life-threatening asthma occurred within 5 years prior to baseline. 8. Allergen immunotherapy was administered 8 weeks prior to baseline. 9. Non-selective beta-blockers were used for the first 4 weeks of the baseline period. 10. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening. 11. Severe trauma or major surgery in the 6 months prior to baseline. 12. History of malignant tumor. 13. Combined with serious other systemic diseases. 14. Combined with immunodeficiency disease. 15. A history of infection requiring treatment with systemic anti-infective drugs in the 4 weeks prior to baseline. 16. Parasitic infection was present in the 6 months prior to baseline. 17. Abnormal laboratory tests during screening or baseline. Screening or baseline ECG results were abnormal and clinically significant. 18. At the time of screening, smokers were still smoking or had quit for less than 6 months, or had a smoking history of ≥10 pack-years. 19. Alcohol consumption within 1 month prior to baseline. 20. History of drug abuse and drug use within 1 year before screening. 21. Those who had a history of blood donation within 4 weeks prior to baseline, or had significant blood loss, or had received a blood transfusion within 8 weeks. 22. People who received live (attenuated) vaccine or viral vector vaccine within 8 weeks prior to the baseline period or planned to receive it during the trial. 23. Researchers and relevant staff of research centres or others directly involved in programme implementation. 24. The investigator considers that there are any circumstances that may cause subjects to be unable to complete the study or present a significant risk to subjects or other factors that may reduce the likelihood of enrollment.

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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 First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510030, China

More trials for these conditions

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