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| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
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This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 multiple doses in participants with asthma. The study plans to enroll participants with asthma on stable inhaled treatment, FeNO≥25ppb at screening and randomization, elevated peripheral blood eosinophils and Pre-BD FEV1 ≤ 80% of the prediction. The safety, tolerability, PK, immunogenicity and changes in PD and clinical characteristics of multiple doses of IBI3002 in asthma subjects will be evaluated.
The entire study includes the screening period (4 weeks before dosing), the treatment period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with asthma, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants will remain blind within the cohort.
Cohort 1: 150mg SC(IBI3002: placebo =2 :1); Cohort 2: 300mg SC(IBI3002: placebo =2 :1); Cohort 3: 600mg SC(IBI3002: placebo =2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3002 600mg SC | Experimental | Participants with asthma will receive IBI3002 600mg SC |
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| IBI3002 150mg SC | Experimental | Participants with asthma will receive IBI3002 150mg SC |
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| Placebo 4ml SC | Placebo Comparator | Participants with asthma will receive Placebo 4ml SC |
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| Placebo 1ml SC | Placebo Comparator | Participants with asthma will receive Placebo 1ml SC |
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| Placebo 2ml SC | Placebo Comparator | Participants with asthma will receive Placebo 2ml SC |
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| IBI3002 300mg SC | Experimental | Participants with asthma will receive IBI3002 300mg SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants with asthma will receive Placebo at the corresponding dose and dosing interval. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of multiple doses of IBI3002 in participants with asthma | The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with asthma after multiple administrations of IBI3002; | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic (PK) parameters of IBI3002 in participants with asthma | PK parameters include, the maximum concentration (Cmax), after multiple doses. | Baseline to Week 20 |
| To evaluate the pharmacokinetic (PK) parameters of IBI3002 in participants with asthma |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wensheng Zang | Contact | 15210342569 | wensheng.zang@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| IBI3002 | Drug | Participants with asthma will receive IBI3002 at the corresponding dose and dosing interval. |
|
PK parameters include, the maximum concentration (Tmax), after multiple doses. |
| Baseline to Week 20 |
| To evaluate the pharmacokinetic (PK) parameters of IBI3002 in participants with asthma | PK parameters include, the maximum concentration (AUC), after multiple doses. | Baseline to Week 20 |
| To evaluate the pharmacokinetic (PK) parameters of IBI3002 in participants with asthma | PK parameters include the trough concentration (Cmin) after multiple doses. | Baseline to Week 20 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |