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

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

Study Overview

• Status: Completed
• Conditions: Adolescent Asthma
• Intervention / Treatment: Drug: SHR-1905 Injection

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1905 Injection	Drug: SHR-1905 Injection; SHR-1905 Injection,medium dose, administered by subcutaneous injection;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK index: Serum SHR-1905 concentration。	Day 253
PK index: Area under the plasma concentration versus time curve (AUC)。	Day 253
PK index: Peak Plasma Concentration (Cmax）。	Day 253
safety: Incidence and severity of any adverse events。	Day 253

Secondary Outcome Measures

Outcome Measure	Time Frame
PD index: Change of peripheral blood eosinophils absolute value (EOS) from baseline.	Day 253
Initial efficacy measures: Changes in forced expiratory volume in the first second (FEV1) from baseline.	Day 253
Initial efficacy measures: Changes in exhaled nitric oxide (FeNO) from baseline.	Day 253

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: SHR-1905-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No