A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of treatment subjects with treatment-related changes in heart rate
研究概览
简要总结
A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Volunteers
详细描述
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of BLD-0409 in healthy volunteers (HV) to facilitate the dose/dosing regimen selection for future clinical studies with BLD-0409 in various chronic liver diseases.
The study consists of two parts:
Part 1: SAD in HV with up to 6 cohorts (including a food effect cohort). For SAD cohorts and planned dosing schedule.
Part 2: MAD over 14 days with up to 6 cohorts. For MAD cohorts and planned dosing schedule.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1SAD/Part 2 MAD:Active Treatment(BLD-0409)
For each cohort in both study parts, 6 subjects will be randomized to active (BLD-0409). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s)
干预措施: BLD-0409 (Drug)
结局指标
主要结局
Number of treatment subjects with treatment-related changes in heart rate
时间窗: up to 56 days
Assessed by collecting and evaluating any observed changes in heart rate. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in hematology clinical laboratory test results.
时间窗: up to 56 days
Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of treatment subjects with treatment-related changes in systolic & diastolic blood pressure
时间窗: up to 56 days
Assessed by collecting and evaluating any observed changes in systolic \& diastolic blod pressure. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in ECG tracings
时间窗: up to 56 days
Assessed by performing 12-lead ECGs, and evaluating ECG tracings from baseline, by dose. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Incidence of Adverse Events (AEs)
时间窗: up to 56 days
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Number of treatment subjects with treatment-related changes in body temperature
时间窗: up to 56 days
Assessed by collecting body temperature using a thermometer. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in urinalysis clinical laboratory test results.
时间窗: up to 56 days
Assessed by collecting and analyzing subjects' urine from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of subjects with treatment-related subjects changes in physical examinations
时间窗: up to 56 days
Assessed by performing physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes, from baseline by dose, through out the study. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in QTc intervals
时间窗: up to 56 days
Assessed by performing 12-lead ECGs, and evaluating QTc intervals from baseline, by dose. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in chemistry clinical laboratory test results.
时间窗: up to 56 days
Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in serology clinical laboratory test results.
时间窗: up to 56 days
Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
次要结局
- Area under the drug concentration-time curve from time zero to the last measurable concentration (AUClast)(up to 56 days)
- Area under the drug concentration time curve from time 0 to infinity (AUC0-inf)(up to 56 days)
- Time of the maximum drug concentration (tmax)(up to 56 days)
- Apparent terminal elimination rate constant (kel)(up to 56 days)
- Apparent elimination half life (t½)(up to 56 days)
- Any observed Changes in serum Lysophosphatidic Acid Receptor (LPA) C18:2(up to 56 days)
- Apparent oral clearance(up to 56 days)
- Apparent terminal volume of distribution(up to 56 days)
- Amount excreted during each collection interval (Ae(t'-t''))(up to 56 days)
- Total amount of drug excreted unchanged in the urine over the entire period of sample collection(up to 56 days)
- Percentage of dose excreted unchanged during each collection interval (Fe(t' t")) and over the entire period of sample collection(up to 56 days)
- Maximum observed drug concentration (Cmax)(up to 56 days)
- Renal clearance (CLr) for each collection interval and over the entire period of sample collection(up to 56 days)