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This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 610 30mg group | Experimental | 610 30 mg administered subcutaneously every 4 weeks |
|
| 610 100mg group | Experimental | 610 100 mg administered subcutaneously every 4 weeks |
|
| 610 300mg group | Experimental | 610 300mg administered subcutaneously every 4 weeks |
|
| Placebo 30mg group | Placebo Comparator | placebo subcutaneous (SC) Q4W,8 times |
|
| Placebo 100mg group | Placebo Comparator | placebo subcutaneous (SC) Q4W,8 times |
|
| Placebo 300mg group | Placebo Comparator | placebo subcutaneous (SC) Q4W,8 times |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 610 30mg group | Drug | 610 30mg subcutaneous (SC) Q4W,8 times |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 0 to Day 308 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-Tmax | Time to Cmax of 610 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinghong Zhou, MD | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Study Director |
| Xin Zhou, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Min Zhang, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| 610 100mg group |
| Drug |
610 100mg subcutaneous (SC) Q4W,8 times |
|
| 610 300mg group | Drug | 610 300mg subcutaneous (SC) Q4W,8 times |
|
| Placebo 30mg group | Other | placebo subcutaneous (SC) Q4W,8 times |
|
| Placebo 100mg group | Other | placebo subcutaneous (SC) Q4W,8 times |
|
| Placebo 300mg group | Other | placebo subcutaneous (SC) Q4W,8 times |
|
| From Day 0 to Day 308 |
| Pharmacokinetics-AUC0-inf | Area under the concentration-time curve from time 0 to infinity after 610 subcutaneous | From Day 0 to Day 308 |
| Pharmacokinetics-Cmax | Maximum observed concentration of 610 | From Day 0 to Day 308 |
| Pharmacokinetics-CL/F | Apparent clearance of 610 | From Day 0 to Day 308 |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of 610 | From Day 0 to Day 308 |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of 610 | From Day 0 to Day 308 |
| Pharmacodynamics-Eosinophils | Absolute eosinophils account and change from baseline in percentage | From Day 0 to Day 308 |
| Anti-drug-antibody | The percentage of subjects with positive ADA titers over time for 610 | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | From Day 0 to Day 308 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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