Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx(Secukinumab ) in healthy male subjects after a single dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR201 | Experimental |
| |
| Cosentyx (Secukinumab) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR201 | Drug | One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the cure from 0 to infinite | Till Day112 |
| Cmax | The max concentration after drug given | Till Day112 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the cure from 0 to some time | Till Day112 |
| Tmax | The time for drug enlarge to max concentration | Till Day112 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao, Doctor | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cosentyx(Secukinumab ) |
| Drug |
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given |
|
| T1/2 | Half life | Till Day112 |
| Vz/F | Apparent volume of distribution | Till Day112 |
| CL/F | Clearance | Till Day112 |
| Immunogenicity | ADA | Till Day112 |
| AE | Advance event | Till Day112 |
| Evaluation about injection site reactions | Evaluation about injection site reactions | 0 mins, 0.5 hours, 24 hours and 72 hours after drug given |
| ECG | ECG | Till Day112 |
| Incidence of laboratory abnormalities | To be summarized using descriptive statistics | Till Day112 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided