A Phase I, Two Part Study Exploring the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effect of Ascending Doses of BL-8040 in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of subjects with Adverse Events
研究概览
简要总结
The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •BMI between 18 and 30 kg/m2 and Weight ≥ 60 Kg
- •Subjects must be either surgically sterilized (vasectomy), or if their partner is of childbearing potential, must use two methods of contraception, one of which must be a barrier method, from the first dose until 3 months after the last dose
- •Subject is able and willing to comply with the requirements of the protocol
排除标准
- •History of clinically significant disease
- •Any illness within the 4 weeks prior to the screening examination
- •Any history of alcohol and/or drug of abuse addiction and/or active / past (up to 2 years before screening) nicotine consumption
- •Clinically relevant deviation from normal in the physical examination and vital signs at screening or baseline
- •Clinically relevant laboratory abnormalities identified at screening or baseline
- •Positive tests at screening for HIV I & II, hepatitis B and/or hepatitis C in both parts or positive tests for Syphilis, HTLV I & II and Nucleic Acid Test (NAT) for HIV and HBV
- •Positive test for urine drugs of abuse or by anamnesis (Barbiturates, Benzodiazepines, Amphetamines, Opiates, Cocaine, Cannabinoids, Methadone, Phencyclidine, and Tricyclic Antidepressants) and/or positive alcohol blood test
- •Subjects who have lost or donated in excess of 400 mL of blood within 3 months prior to Day 1 of the study
研究组 & 干预措施
Cohort A
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: BL-8040 (Drug)
Cohort A
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: Placebo (Drug)
Cohort B
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: BL-8040 (Drug)
Cohort B
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: Placebo (Drug)
Cohort C
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: BL-8040 (Drug)
Cohort C
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with Adverse Events
时间窗: Up to 7 days after treatment comletion
次要结局
未报告次要终点