Adolescent AsthmaPhase 2NCT06786455
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
A Phase 2 study testing SHR-1905 Injection in people with Adolescent Asthma, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Asthma
- What is being tested?
- SHR-1905 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2025to 3 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Parasitic infection was present in the 6 months prior to baseline.
- Abnormal laboratory tests during screening or baseline. Screening or baseline ECG results were abnormal and clinically significant.
- 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.
- Alcohol consumption within 1 month prior to baseline.
- History of drug abuse and drug use within 1 year before screening.
- 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.
- 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.
- Researchers and relevant staff of research centres or others directly involved in programme implementation.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510030
About this 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
- Conditions
- Adolescent Asthma
- Being tested
- SHR-1905 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1905 InjectionDrug
SHR-1905 Injection,medium dose, administered by subcutaneous injection;
| Study group | Role | What they receive |
|---|---|---|
| SHR-1905 Injection | Experimental | Not described Receives: Drug: SHR-1905 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK index: Serum SHR-1905 concentration。
Measured: Day 253
PK index: Area under the plasma concentration versus time curve (AUC)。
Measured: Day 253
PK index: Peak Plasma Concentration (Cmax）。
Measured: Day 253
safety: Incidence and severity of any adverse events。
Measured: Day 253
Secondary outcomes (3)
PD index: Change of peripheral blood eosinophils absolute value (EOS) from baseline.
Measured: Day 253
Initial efficacy measures: Changes in forced expiratory volume in the first second (FEV1) from baseline.
Measured: Day 253
Initial efficacy measures: Changes in exhaled nitric oxide (FeNO) from baseline.
Measured: Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start23 Jan 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent AsthmaStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786455
- Sponsor's protocol ID
- SHR-1905-204
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06786455
- Acronym / sponsor ID
- SHR-1905-204
- Conditions
- Adolescent Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1905 Injection | Experimental | Drug: SHR-1905 Injection |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1905 InjectionSHR-1905 Injection,medium dose, administered by subcutaneous injection; | Drug | SHR-1905 Injection |
Primary outcome
PK index: Serum SHR-1905 concentration。
Time frame: Day 253
PK index: Area under the plasma concentration versus time curve (AUC)。
Time frame: Day 253
PK index: Peak Plasma Concentration (Cmax）。
Time frame: Day 253
safety: Incidence and severity of any adverse events。
Time frame: Day 253
3 secondary outcomes
PD index: Change of peripheral blood eosinophils absolute value (EOS) from baseline.
Time frame: Day 253
Initial efficacy measures: Changes in forced expiratory volume in the first second (FEV1) from baseline.
Time frame: Day 253
Initial efficacy measures: Changes in exhaled nitric oxide (FeNO) from baseline.
Time frame: Day 253
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1905 Injection in people with Adolescent Asthma, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK index: Serum SHR-1905 concentration。 (time frame: Day 253). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.