This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors \[AI\] (test) versus dual-chamber syringes \[DCS\] (reference) under controlled conditions in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Nemolizumab with Auto-Injector (AI).
Nemolizumab with Dual-Chamber Syringe (DCS).
Galderma Investigational Site 7024
Tempe, Arizona, United States
Galderma Investigational Site 7023
Lincoln, Nebraska, United States
Maximum Observed Plasma Concentration (Cmax) of Nemolizumab
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab
AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose
Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab
AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Tmax was defined as the time taken to reach the maximum observed serum concentration.
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Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Half-life (t1/2) of Nemolizumab
t1/2 is defined as time required for the concentration of the drug to reach half of its original value.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Time frame: Pre-dose, Day 29 and 85 post-dose