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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.10 g/day of AP301 | Experimental |
| |
| 4.20 g/day of AP301 | Experimental |
| |
| 6.30 g/day of AP301 | Experimental |
| |
| 8.40 g.day of AP301 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP301 | Drug | Orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary phosphorus excretion during AP301 administration | Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment | 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. | 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. | 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. | 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. | From Day -3 to Day 4 after dosing, assessed up to 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From screening to hospitalization and follow up periods, assessed up to 43 days |
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Important Inclusion Criteria:
Important Exclusion Criteria:
Male
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| Name | Affiliation | Role |
|---|---|---|
| Sam Francis, Doctor | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia |
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| Changes in clinical laboratory values |
Changes and their clinical meaningfulness in clinical laboratory values: Hematology, Biochemistry, Urinalysis |
| 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 | 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. | 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 | From screening to hospitalization and follow up periods, assessed up to 43 days |