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| Name | Class |
|---|---|
| Affiliated Hospital of North Sichuan Medical College | OTHER |
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To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genakumab injection | Experimental | Group 1: 120mg,group 2: 200mg |
|
| placebo | Placebo Comparator | The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab injection | Drug | Group 1: 120mg Q4W,group 2: 200mg Q4W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse events (AE) | adverse events during the study are to assess the safety of Genakumab. | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum Genakumab concentration | This is to assess pharma co kinetics of Genakumab. | up to 20 weeks |
| Area under the serum Genakumab concentration-time curve | This is to assess pharma co kinetics of Genakumab. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolan Yong, bachelor | Chengdu Xinhua Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| placebo |
| Drug |
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection. |
|
| up to 20 weeks |