This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.
A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Orally administered
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Urinary phosphorus excretion during AP301 administration
Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment
Time frame: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary phosphorus excretion
Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Urinary calcium excretion during AP301 administration
Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.
Time frame: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary calcium excretion
Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Effect of AP301 on serum phosphorus and calcium
Changes of serum phosphorus and serum calcium from baseline to end of treatment.
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Incidence and severity of adverse events (AEs)
Number of participants with adverse events (AEs) and the intensity of adverse events. Number of participants with serious adverse events (SAEs) and the intensity of adverse events.
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes in clinical laboratory values
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Changes and their clinical meaningfulness in clinical laboratory values: Hematology, Biochemistry, Urinalysis
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness
ECG intervals (PR \[PQ\], QRS, QT, QTcF) and heart rate
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes of ECG parameters and their clinical meaningfulness
ECG intervals (PR \[PQ\], QRS, QT, QTcF), heart rate, T-wave morphology and U-wave morphology.
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal vital signs and their clinical meaningfulness
Blood pressure, heart rate and body temperature
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days