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This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part B IBI3002 dose 5 SC | Experimental | Patients with asthma will receive IBI3002 dose 5 SC at Week 0, 2, 4, 6, 8 and 10 |
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| Part B Placebo | Placebo Comparator | Patients with asthma will receive matched placebo |
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| Part A IBI3002 dose2 SC | Experimental | Healthy Participants will receive IBI3002 dose 2 SC at Week 0, 2, 4, and 6 |
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| Part A IBI3002 dose 4 SC | Experimental | Healthy Participants will receive IBI3002 dose 4 SC at Week 0, 2, 4, and 6 |
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| Part B IBI3002 dose 2 SC | Experimental | Patients with asthma will receive IBI3002 dose 2 SC at Week 0, 2, 4, 6, 8 and 10 |
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| Part A Placebo | Placebo Comparator | Healthy Participants will receive matched placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Healthy participants and patients with asthma will receive matched placebo. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | Incidence of adverse events (AEs) and serious adverse events (SAEs) after IBI3002 multiple doses in healthy participants; | baseline to Week16 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | PK parameters include, the maximum concentration (Cmax), after multiple doses. | baseline to Week16 |
| To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. |
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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.](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-japan Friendship Hosipital | Beijing | Beijing Municipality | 100192 | 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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| Part A IBI3002 dose 3 IV | Experimental | Healthy Participants will receive IBI3002 dose 3 IV at Week 0, 2, 4, and 6 |
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| Part A IBI3002 dose 5 SC | Experimental | Healthy Participants will receive IBI3002 dose 5 SC at Week 0, 2, 4, and 6 |
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| Part A IBI3002 dose1 SC | Experimental | Healthy Participants will receive IBI3002 dose1 SC at Week 0, 4 and 8 |
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| IBI3002 | Drug | Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval. |
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PK parameters include, the time to achieve Cmax (Tmax), after multiple doses. |
| baseline to Week16 |
| To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | PK parameters include, the area under the concentration-time curve (AUC) ,after multiple doses. | baseline to Week16 |
| To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | PK parameters include the trough concentration (Cmin) after multiple doses. | baseline to Week16 |
| To assess the incidence of immunogenicity of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | the incidence of immunogenicity of IBI3002. | baseline to Week16 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |