A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Effect of AP301 on urinary phosphorus excretion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, 18-55 years of age
- •Body mass index (BMI) 18-30 kg/m2 (exclusive) at screening.
排除标准
- •Serum phosphorus is below 1.00 mmol/L at screening.
- •History of significant gastrointestinal disease or disorder, major gastrointestinal surgeries, or cholecystectomy
- •History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological diseases, or cancer.
- •History of specific allergies or allergic conditions or known allergies to the study drug as judged by the investigator, or any confirmed significant allergic reactions (urticaria or anaphylaxis) to any drug, or multiple drug allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
- •Known history of allergy to common food like milk or gluten, or lactose intolerance, or special diet habit for religious/life-style reasons, which might potentially jeopardize the participant's compliance of study diet.
- •Any clinically significant concomitant disease, or condition or treatment that could interfere with the conduct of the study.
- •Confirmed (based on the average of 3 separate resting blood pressure measurements, after at least 5 minutes rest) systolic blood pressure (BP) greater than 150 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
- •Clinically relevant ECG abnormalities on screening ECG.
- •Estimated glomerular filtration rate (eGFR) ≤ 70 mL/min/1.73 m
- •Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCV Ab) or human immunodeficiency virus (HIV-1 or HIV-2 Ab).
- •Alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5 × upper limit of normal (ULN), or any other clinically significant abnormalities in laboratory test results at screening.
- •Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives (whichever is the longer) prior to first dose of this study.
- •Positive urine test for drugs of abuse and/or positive alcohol test at screening.
- •Any medical or social conditions that, in the view of investigator, might potentially jeopardize the participant's compliance of study.
研究组 & 干预措施
8.40 g.day of AP301
干预措施: AP301 (Drug)
2.10 g/day of AP301
干预措施: AP301 (Drug)
4.20 g/day of AP301
干预措施: AP301 (Drug)
6.30 g/day of AP301
干预措施: AP301 (Drug)
结局指标
主要结局
Effect of AP301 on urinary phosphorus excretion
时间窗: From Day -3 to Day 4 after dosing, assessed up to 6 days
Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.
Effect of AP301 on urinary calcium excretion
时间窗: From Day -3 to Day 4 after dosing, assessed up to 6 days
Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.
Urinary calcium excretion during AP301 administration
时间窗: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.
Urinary phosphorus excretion during AP301 administration
时间窗: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment
Effect of AP301 on serum phosphorus and calcium
时间窗: From Day -3 to Day 4 after dosing, assessed up to 6 days
Changes of serum phosphorus and serum calcium from baseline to end of treatment.
次要结局
- Changes in clinical laboratory values(From screening to hospitalization and follow up periods, assessed up to 43 days)
- Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness(From screening to hospitalization and follow up periods, assessed up to 43 days)
- Abnormal vital signs and their clinical meaningfulness(From screening to hospitalization and follow up periods, assessed up to 43 days)
- Incidence and severity of adverse events (AEs)(From screening to hospitalization and follow up periods, assessed up to 43 days)
- Changes of ECG parameters and their clinical meaningfulness(From screening to hospitalization and follow up periods, assessed up to 43 days)