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
Not provided
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test preparation(T) | Experimental | Genakumab Solution for Injection (T, liquid formulation) |
|
| Reference preparation(R) | Experimental | Genakumab Powder for solution for Injection (R, lyophilized formulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab Injection (T, Solution for injection) | Drug | A single dose of subcutaneous injection of Genakumab(Solution for injection, liquid formulation)200 mg on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Area under the concentration-time curve (AUC), of Genakumab Injection with Genakumab for Injection | 0 hours -3360 hours post-administration | |
| Pharmacokinetics (Peak Plasma Concentration (Cmax))of Genakumab Injection with Genakumab for Injection | 0 hours -3360 hours post-administration | |
| Pharmacokinetics (Peak time (Tmax) of Genakumab Injection with Genakumab for Injection | 0 hours -3360 hours post-administration | |
| Pharmacokinetics (The elimination half-life (T1/2) of Genakumab Injection with Genakumab for Injection | 0 hours -3360 hours post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability(Number of participants with treatment-related adverse events) | up to approximately 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug antibody (Number of Participants with positive ADA) | 0 hours -3360 hours post-administration |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital | Chengdu | Sichuan | 610000 | China |
Not provided
| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| D011208 | Powders |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Genakumab for Injection (R, Powder for solution for injection) | Drug | A single dose of subcutaneous injection of Genakumab(Powder for solution for injection, lyophilized formulation) 200 mg on Day 1 |
|
| D000070657 |
| Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004304 |
| Dosage Forms |