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

NCT06786455 | Completed Phase 2

• 1 other identifier: SHR-1905-204
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adolescent Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (1)

SHR-1905 Injection

EXPERIMENTAL

Drug: SHR-1905 Injection

Interventions

SHR-1905 Injection DRUG

SHR-1905 Injection,medium dose, administered by subcutaneous injection;

SHR-1905 Injection

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The age of signing the informed consent must be ≥12 years old and \<18 years old, both male and female.
• Body weight ≥30 kg and BMI≥18 kg/m2.
• The clinical diagnosis was asthma for at least 6 months.
• Subjects receiving asthma maintenance therapy were required to maintain a stable dose for 4 weeks prior to baseline.
• FEV1/ estimated value of pre-BD before bronchodilator in screening period must be ≥40%.
• Screening period bronchial dilation test or bronchial excitation test positive.
• Informed consent was signed before the trial.
• Potentially fertile subjects voluntarily take appropriate contraceptive measures.

You may not qualify if:

• Combined with clinically significant lung disease other than asthma
• A combination of diseases other than asthma that may affect lung function
• 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.
• Bronchial thermoplasty or bronchial cryoablation were performed within 1 year prior to baseline.
• Acute asthma attacks requiring systemic glucocorticoid use for ≥3 days occurred within 1 month prior to baseline.
• Systemic glucocorticoids were used as maintenance therapy for the first 3 months of the baseline period.
• Acute episodes of life-threatening asthma occurred within 5 years prior to baseline.
• Allergen immunotherapy was administered 8 weeks prior to baseline.
• Non-selective beta-blockers were used for the first 4 weeks of the baseline period.
• Participated in clinical trials of any drug or medical device within 12 weeks prior to screening.
• Severe trauma or major surgery in the 6 months prior to baseline.
• History of malignant tumor.
• Combined with serious other systemic diseases.
• Combined with immunodeficiency disease.
• A history of infection requiring treatment with systemic anti-infective drugs in the 4 weeks prior to baseline.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510030, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: January 23, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CN (1)