A Randomised, First-in-human, Double-blinded, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CP1050 in Healthy Subjects; Including the Effect of Food and Gender on the Pharmacokinetics and Pharmacodynamics of a Single Dose of CP1050 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])
研究概览
简要总结
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
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
- Triple (Participant, 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
- •Caucasian males or females between 18 and 55 years of age (inclusive).
- •A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
- •Healthy and free from clinically significant illness or disease.
排除标准
- •Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
- •Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
- •Clinically significant abnormalities in ECG or laboratory tests.
研究组 & 干预措施
Single ascending dose, CP1050 or Placebo
干预措施: CP1050 or Placebo (Drug)
Multiple ascending dose, CP1050 or Placebo
干预措施: CP1050 or Placebo (Drug)
结局指标
主要结局
Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG
Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria)
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG
Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs
Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments
Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests
Number of subjects with abnormal physical examinations
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations
Incidence and severity of any drug-related adverse events
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
时间窗: Up to 21 days
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests
次要结局
- Apparent plasma terminal elimination half-life (T1/2)(Up to 21 days)
- Maximum observed plasma concentration (Cmax)(Up to 21 days)
- Time of nadir (Tnadir)(Up to 21 days)
- Area under the effectiveness curve (AUCE)(Up to 21 days)
- The lowest absolute value of lymphocytes at postdose (nadir)(Up to 21 days)
- The lowest percentage of baseline (nadir [%])(Up to 21 days)
- Area under the plasma concentration-time curve (AUC)(Up to 21 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 21 days)