NCT03789734已完成1 期
A Dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22 Following Single/Multiple Oral Administration in Healthy Adult Volunteers
BioLeaders Corporation2 个研究点 分布在 2 个国家目标入组 37 人开始时间: 2019年6月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm the safety of BLS-M22.
详细描述
This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22.
The single ascending dose group participated in 9 patients in each group(500mg, 1,000mg, 2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10 patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between 19-55 years of age
- •BMI: 19~28kg/m2(male), 18~25kg/m2(female) at screening test
- •Able to provide consent to participate and having signed an Informed Consent Form (ICF)
- •The subjects can obey the demands of the scheme
排除标准
- •Subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system.
- •Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug
- •Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization
- •Subject has received steroids or other immunosuppressive drugs within 30 days of randomization
- •Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis
- •Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm
- •Pregnant women
- •Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subject has abnormal clinical laboratory test results
- •Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
结局指标
主要结局
Adverse events
时间窗: up to 4-5 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- AUClast(From 0 hours to 24 hours)
- Immunogenicity(Myostatin specific IgG level in serum)(up to 4-5 weeks)
研究者
研究点 (2)
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