AsthmaPhase 1NCT05584306
A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
A Phase 1 study testing 610 30mg group, 610 100mg group and 610 300mg group in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- 610 30mg group, 610 100mg group and 610 300mg group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to Sep 2023
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with asthma for ≥12 months
- Within 3 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily.）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- In the past 12 months prior to screening， at least one time asthma exacerbations history
- Pre-bronchodilator FEV1 <80% predicted value
- Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration
Who cannot join
- With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
- With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
- In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
- with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
- poorly controlled systemic disease
- Active infection 7 day before screening
Show all 11Show fewer
- Parasitic infection within 6 months before screening
- At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
- Subjects who have received any monoclonal antibody treatment of anti IL-4Ror anti-IL-5/5R
- Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
- Participated in any interventional clinical trial and received intervention within 3 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.
- Conditions
- Asthma
- Being tested
- 610 30mg group, 610 100mg group, 610 300mg group, Placebo 30mg group, Placebo 100mg group
- Keywords
- Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
610 30mg groupDrug
610 30mg subcutaneous (SC) Q4W，8 times
610 100mg groupDrug
610 100mg subcutaneous (SC) Q4W，8 times
610 300mg groupDrug
610 300mg subcutaneous (SC) Q4W，8 times
Placebo 30mg groupOther
placebo subcutaneous (SC) Q4W，8 times
Placebo 100mg groupOther
placebo subcutaneous (SC) Q4W，8 times
Placebo 300mg groupOther
placebo subcutaneous (SC) Q4W，8 times
| Study group | Role | What they receive |
|---|---|---|
| 610 30mg group | Experimental | 610 30 mg administered subcutaneously every 4 weeks Receives: Drug: 610 30mg group |
| 610 100mg group | Experimental | 610 100 mg administered subcutaneously every 4 weeks Receives: Drug: 610 100mg group |
| 610 300mg group | Experimental | 610 300mg administered subcutaneously every 4 weeks Receives: Drug: 610 300mg group |
| Placebo 30mg group | Placebo comparator | placebo subcutaneous (SC) Q4W，8 times Receives: Other: Placebo 30mg group |
| Placebo 100mg group | Placebo comparator | placebo subcutaneous (SC) Q4W，8 times Receives: Other: Placebo 100mg group |
| Placebo 300mg group | Placebo comparator | placebo subcutaneous (SC) Q4W，8 times Receives: Other: Placebo 300mg group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events(AEs)
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
Measured: From Day 0 to Day 308
Secondary outcomes (17)
Pharmacokinetics-Tmax
Time to Cmax of 610
Measured: From Day 0 to Day 308
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after 610 subcutaneous
Measured: From Day 0 to Day 308
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after 610 subcutaneous
Measured: From Day 0 to Day 308
Pharmacokinetics-Cmax
Maximum observed concentration of 610
Measured: From Day 0 to Day 308
Pharmacokinetics-CL/F
Apparent clearance of 610
Measured: From Day 0 to Day 308
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of 610
Measured: From Day 0 to Day 308
Pharmacokinetics-t1/2
Terminal elimination half-life of 610
Measured: From Day 0 to Day 308
Pharmacodynamics-Eosinophils
Absolute eosinophils account and change from baseline in percentage
Measured: From Day 0 to Day 308
Anti-drug-antibody
The percentage of subjects with positive ADA titers over time for 610
Measured: From Day 0 to Day 308
Number of asthma exacerbation
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Measured: From Day 0 to Day 308
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Measured: From Day 0 to Day 308
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Percentage of FEV1 will be measured using spirometry.
Measured: From Day 0 to Day 308
Time to first asthma exacerbation event
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Measured: From Day 0 to Day 308
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Measured: From Day 0 to Day 308
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Asthma exacerbations that are associated with a hospitalization.
Measured: From Day 0 to Day 308
Change from baseline in Asthma Control Questionnaire score
The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment).
Measured: From Day 0 to Day 308
Change From Baseline in the St. George's Respiratory Questionnaire Total Score
The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health.
Measured: From Day 0 to Day 308
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start6 Dec 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, MD, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Xin Zhou, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineMin Zhang, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584306
- Sponsor's protocol ID
- SSGJ-610-BA-I/II-01
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT05584306
- Acronym / sponsor ID
- SSGJ-610-BA-I/II-01
- Conditions
- Asthma
- Keywords
- Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 610 30mg group | Experimental | Drug: 610 30mg group610 30 mg administered subcutaneously every 4 weeks |
| 610 100mg group | Experimental | Drug: 610 100mg group610 100 mg administered subcutaneously every 4 weeks |
| 610 300mg group | Experimental | Drug: 610 300mg group610 300mg administered subcutaneously every 4 weeks |
| Placebo 30mg group | Placebo comparator | Other: Placebo 30mg groupplacebo subcutaneous (SC) Q4W，8 times |
| Placebo 100mg group | Placebo comparator | Other: Placebo 100mg groupplacebo subcutaneous (SC) Q4W，8 times |
| Placebo 300mg group | Placebo comparator | Other: Placebo 300mg groupplacebo subcutaneous (SC) Q4W，8 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with asthma for ≥12 months
- Within 3 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily.）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- In the past 12 months prior to screening， at least one time asthma exacerbations history
- Pre-bronchodilator FEV1 <80% predicted value
- Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration
Key exclusion criteria (11 listed)
- With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
- With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
- In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
- with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
- poorly controlled systemic disease
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 |
|---|---|---|
| 610 30mg group610 30mg subcutaneous (SC) Q4W，8 times | Drug | 610 30mg group |
| 610 100mg group610 100mg subcutaneous (SC) Q4W，8 times | Drug | 610 100mg group |
| 610 300mg group610 300mg subcutaneous (SC) Q4W，8 times | Drug | 610 300mg group |
| Placebo 30mg groupplacebo subcutaneous (SC) Q4W，8 times | Other | Placebo 30mg group |
| Placebo 100mg groupplacebo subcutaneous (SC) Q4W，8 times | Other | Placebo 100mg group |
| Placebo 300mg groupplacebo subcutaneous (SC) Q4W，8 times | Other | Placebo 300mg group |
Primary outcome
Adverse events(AEs)
Time frame: From Day 0 to Day 308
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
17 secondary outcomes
Pharmacokinetics-Tmax
Time frame: From Day 0 to Day 308
Pharmacokinetics-AUC0-last
Time frame: From Day 0 to Day 308
Pharmacokinetics-AUC0-inf
Time frame: From Day 0 to Day 308
Pharmacokinetics-Cmax
Time frame: From Day 0 to Day 308
Pharmacokinetics-CL/F
Time frame: From Day 0 to Day 308
Pharmacokinetics-Vz/F
Time frame: From Day 0 to Day 308
Pharmacokinetics-t1/2
Time frame: From Day 0 to Day 308
Pharmacodynamics-Eosinophils
Time frame: From Day 0 to Day 308
Anti-drug-antibody
Time frame: From Day 0 to Day 308
Number of asthma exacerbation
Time frame: From Day 0 to Day 308
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Time frame: From Day 0 to Day 308
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Time frame: From Day 0 to Day 308
Time to first asthma exacerbation event
Time frame: From Day 0 to Day 308
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
Time frame: From Day 0 to Day 308
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Time frame: From Day 0 to Day 308
Change from baseline in Asthma Control Questionnaire score
Time frame: From Day 0 to Day 308
Change From Baseline in the St. George's Respiratory Questionnaire Total Score
Time frame: From Day 0 to Day 308
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Qinghong Zhou, MD study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Xin Zhou, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Min Zhang, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 610 30mg group, 610 100mg group and 610 300mg group in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Adverse events(AEs) (time frame: From Day 0 to Day 308). 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 Oct 2022.