A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under Fasting Conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
238
Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng
Zhengzhou, China
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
The Maximum Serum Drug Concentration (Cmax)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
The Time to Maximum Serum Concentration(Tmax)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
The Elimination Half-life (t1/2)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Elimination Rate Constant (Kel)
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pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Volumeof Distribution (Vd/F)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Clearance(CL/F)
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
Time frame: 0 to 1536 hours post-dose
Immunogenicity Estimands
Presence of anti-adalimumab antibodies
Time frame: Day1 to Day 65
Safety Estimands
Frequency of Adverse Events
Time frame: Day1 to Day 65