A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
研究概览
简要总结
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
详细描述
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- •Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- •Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- •Male participants with partners of childbearing potential must agree to use effective contraception.
排除标准
- •Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
- •Recent hospitalization or a significant acute medical event.
- •History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
- •Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -
- •Positive test for hepatitis B, hepatitis C, or HIV.
研究组 & 干预措施
BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
干预措施: BW-50218 Injection (Drug)
BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
干预措施: BW-50218 Injection (Drug)
BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
干预措施: BW-50218 Injection (Drug)
Saline Placebo
Single dose of Saline Placebo
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
时间窗: From baseline up to Day 360 (End of Study)
Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged.
Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
时间窗: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
时间窗: From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
时间窗: From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Change from Baseline in Physical Examination Findings
时间窗: From baseline up to Day 360 (End of Study)
Assessment of clinically significant changes in physical examination findings
Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
时间窗: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
次要结局
- Urine Pharmacokinetic Parameters (Renal Clearance, CLr)(From pre-dose up to 24 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax)(From pre-dose up to Day 8)
- Time to Maximum Plasma Concentration (Tmax)(From pre-dose up to Day 8)
- Area Under the Plasma Concentration-Time Curve (AUC)(From pre-dose up to Day 8)
- Terminal Elimination Half-Life (t1/2)(From pre-dose up to Day 8)