The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is: Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)). Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use. Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
IGT-303 administered via IV or SC
Saline
Nucleus Network
Herston, Brisbane, Australia
RECRUITINGAdverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
The number and severity (by Grade) will be measured.
Time frame: From Screening to Day 84.
PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303
Maximum observed concentration (Cmax)
Time frame: Day 1 to Day 84.
PK Parameters of IV and SC IGT-303
Observed time of maximum concentration (Tmax)
Time frame: Day 1 to Day 84
PK Parameters of IV and SC IGT-303
Terminal exponential rate constant, determined using the linear least squares regression of the terminal phase of the log-serum concentration time profile (λz)
Time frame: Day 1 to Day 84
PK Parameters of IV and SC IGT-303
Terminal exponential half-life, calculated as ln(2)/λz (T1/2)
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Area under the concentration-time curve calculated using linear trapezoidal rule from time zero to time t, where t is the time of the last observed quantifiable concentration (AUC0-t)
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Area under the concentration-time curve from time zero to infinity, defined as AUC0-t + Ct/λz (AUC0-∞)
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Total clearance (CL), defined as dose/AUC0-∞
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Terminal volume of distribution (Vz), defined as CL/λz
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Absolute bioavailability (F), defined as the dose-corrected (AUC0-∞ SC) / (AUC0-∞ IV)
Time frame: Day 1 to Day 84
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