Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study
NCT ID: NCT06786455
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2025-01-23
2025-12-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-1905 Injection
SHR-1905 Injection
SHR-1905 Injection,medium dose, administered by subcutaneous injection;
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-1905 Injection
SHR-1905 Injection,medium dose, administered by subcutaneous injection;
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
12 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-1905-204
Identifier Type: -
Identifier Source: org_study_id