A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
37
MEDI0382 administered subcutaneously
Research Site
Kiel, Germany
Research Site
München, Germany
Research Site
Auckland, New Zealand
Research Site
Christchurch, New Zealand
Maximum Observed Concentration of MEDI0382 (Cmax)
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Time frame: 0-48 hours
Area under the Concentration Time Curve (AUC) of MEDI0382
The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations
Time frame: 0-48 hours
Time to maximum observed concentration (Tmax)
Time to maximum observed concentration.
Time frame: 0-48 hours
apparent clearance (Cl/F)
The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)
Time frame: 0-48 hours
AUCinf
The AUC extrapolated to infinity will be calculated, where data permit, as the sum of AUC((0-t) and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant.
Time frame: 0-48 hours
Half-life (T1/2)
The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/z, where z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data
Time frame: 0-48 hours
Anti-drug Antibody (ADA) titer
ADA titer through to day 28
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Time frame: Day -1 to day 28
Number of subjects with Adverse Events
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Time frame: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)
Time frame: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
Time frame: Study onset till 28 days post dosing