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
Not provided
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT630 | Experimental | Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630 |
|
| adalimumab-EU source | Active Comparator | Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT630 | Drug | SCT630 single s.c. injection |
| |
| adalimumab-EU source |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. |
| Cmax | Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-∞ | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of SCT630 and EU-licensed Humira | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. |
| Tmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing SHIJITAN Hospital | Beijing | Beijing Municipality | 100038 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
adalimumab-EU source single s.c. injection |
|
Time to the Maximum Concentration of SCT630 and EU-licensed Humira |
| at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. |
| t1/2 | Elimination Phase Half-life of SCT630 and EU-licensed Humira | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. |
| λz | λz of SCT630 and EU-licensed Humira | Day 1 through Day 71 |
| CL | Clearance rate of the SCT630 and EU-licensed Humira | Day 1 through Day 71 |
| Vd | Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira | Day 1 through Day 71 |
| Number (Proportion) of Subjects With Drug Related Adverse Events | Day 1 through Day 71 |
| Positive rate of ADA and NAb | Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira | Day 1 through Day 71 |