NCT04138849已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 Following Single Doses in Healthy Japanese Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
- •Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
- •Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
- •Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- •Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
- •A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
- •Must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after dosing of study treatment and refrain from donating sperm during this period
- •Be first generation Japanese.
排除标准
- •Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- •Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
- •Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
- •Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
- •Donated plasma within 7 days of Day -1
- •Estimated creatinine clearance <80 mL/min
- •Liver function tests (serum alkaline phosphatase [ALP], aspartate transaminase [AST], alanine aminotransferase [ALT]) and serum bilirubin (total and direct) 1.2 times above the upper limit of normal (ULN) at Screening or Day -
- •Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -
- •Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- •History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -
- •Positive cotinine test at Screening and Day -
- •History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
研究组 & 干预措施
BBT-877 Low Dose
Experimental
干预措施: BBT-877 single dose (Drug)
BBT-877 Mid Dose
Experimental
干预措施: BBT-877 single dose (Drug)
BBT-877 High Dose
Experimental
干预措施: BBT-877 single dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo single dose (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to Day 14.
The number of AEs.
次要结局
- Pharmacokinetics_Cmax (peak concentration)(Day 1 to Day 4)
- Pharmacokinetics_AUC (the area under the curve)(Day 1 to Day 4)
- Pharmacodynamics_plasma LPA (Lysophosphatidic acid)(Day 1 to Day 4)
研究者
研究点 (1)
Loading locations...
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