A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
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Part 1: Number of participants with TEAEs
Timeframe: For up to 44 weeks.
Part 1: Percentage of participants with TEAEs
Timeframe: For up to 44 weeks.
Part 2: Number of participants with TEAEs
Timeframe: For up to 52 weeks.
Part 2: Percentage of participants with TEAEs
Timeframe: For up to 52 weeks.
Part 1: Change from baseline for haematology laboratories values
Timeframe: For up to 44 weeks.
Part 2: Change from baseline for haematology laboratories values
Timeframe: For up to 52 weeks.
Part 1: Change from baseline for clinical chemistry laboratories values
Timeframe: For up to 44 weeks.
Part 2: Change from baseline for clinical chemistry laboratories values
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for FSH
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for FSH
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for estradiol
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for estradiol
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for temperature
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for temperature
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for pulse rate
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for pulse rate
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for respiratory rate
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for respiratory rate
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for systolic and diastolic blood pressure
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for systolic and diastolic blood pressure
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for QT
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for QT
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for QTc
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for QTc
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for QTCF
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for QTCF
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for QRS
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for QRS
Timeframe: For up to 52 weeks.
Part 1: Change from baseline in continuous variables for heart rate
Timeframe: For up to 44 weeks.
Part 2: Change from baseline in continuous variables for heart rate
Timeframe: For up to 52 weeks.
Part 1: The presence or absence of abnormality on ectopic mineralization, any sign of left ventricular hypertrophy or heart failures before and after administration of KK8123 on Echocardiogram
Timeframe: For up to 44 weeks.
Part 2: The presence or absence of abnormality on ectopic mineralization, any sign of left ventricular hypertrophy or heart failures before and after administration of KK8123 on Echocardiogram
Timeframe: For up to 52 weeks.
Part 1: Before and after administration presented at each time point in categorical variables for renal ultrasound
Timeframe: For up to 44 weeks.
Part 2: Before and after administration presented at each time point in categorical variables for renal ultrasound
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by maximum plasma concentration (Cmax)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by maximum plasma concentration (Cmax)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by maximum serum concentration (tmax)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by maximum serum concentration (tmax)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by area under the serum concentration time curve from zero to last detectable time point (AUClast)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by area under the serum concentration time curve from zero to last detectable time point (AUClast)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by the area under the serum concentration time curve from zero to infinity (AUC00-inf)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by the area under the serum concentration time curve from zero to infinity (AUC00-inf)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by apparent volume of distribution (V/F)
Timeframe: For up to 44 weeks..
Part 2: KK8123 concentrations by apparent volume of distribution (V/F)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by terminal half-life (t1/2)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by terminal half-life (t1/2)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by apparent clearance (CL/F)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by apparent clearance (CL/F)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by maximum plasma concentration steady state (Cmax,ss)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by maximum plasma concentration steady state (Cmax,ss)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by time to maximum serum concentration steady state (tmax,ss)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by time to maximum serum concentration steady state (tmax,ss)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations over time by area under the serum concentration curve within a dosing interval at steady state (AUCtau,ss)
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations over time by area under the serum concentration curve within a dosing interval at steady state (AUCtau,ss)
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by time to steady state
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by time to steady state
Timeframe: For up to 52 weeks.
Part 1: KK8123 concentrations by accumulation ratio
Timeframe: For up to 44 weeks.
Part 2: KK8123 concentrations by accumulation ratio
Timeframe: For up to 52 weeks.
Part 1: To evaluate the effect of single and multiple SC administrations of KK8123 on serum phosphorus levels
Timeframe: For up to 44 weeks.
Part 2: To evaluate the effect of multiple SC administrations of KK8123 on serum phosphorus levels
Timeframe: For up to 52 weeks.