This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. \<80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks
PPD Development, LP
Austin, Texas, United States
Peak Plasma Concentration (Cmax)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Time to Maximum Serum Concentration (Tmax)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Half-life (t1/2)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Rate Constant (λz)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Total Body Clearance (CL/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Summary of Immunogenicity Assay
To evaluate immunogenicity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, Days 15, 29, 57, 71 postdose
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