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This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
Healthy volunteers will be randomly assigned in a 1:1 ratio to receive either IBI3027 or DUPIXENT?. The dosage for both groups is 300 mg. The entire study includes a 28-day screening period and a 56-day observation period (including 3 days of hospitalization). Randomization is stratified by body weight at baseline (D1) ≤ 70 kg vs. > 70 kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3027 treatment group | Experimental | The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day. |
|
| DUPIXENT® (dupilumab) treatment group | Active Comparator | The participants in this group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3027 | Drug | The participants in IBI3027 treatment group will receive a 300 mg subcutaneous injection of IBI3027 on the first day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak drug concentration (Cmax) | Days 1-57 | |
| Area under the plasma concentration-time curve (AUC0-∞). | Days 1-57 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUClast) | Days 1-57 | |
| volume of distribution (V/F) | Days 1-57 | |
| clearance rate (CL/F) |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao University Affiliated Hospital | Qingdao | Shandong | Shandong Province | China |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| DUPIXENT® (dupilumab) | Drug | The participants in DUPIXENT® (dupilumab) treatment group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day. |
|
| Days 1-57 |
| Anti-drug antibodies (ADA) | Days 1-57 |
| Neutralizing antibodies (NAb) | Days 1-57 |
| Elimination half-life (t1/2) | Days 1-57 |
| The number and proportion of serious adverse events related to the experimental drug | Days 1-57 |
| The number and proportion of treatment-related adverse events during the trial period | Days 1-57 |