NCT03133130已完成1 期
A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers
Hugel1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年7月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
研究概览
简要总结
Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
详细描述
A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adults, 19 ~ 39 years of age
- •Body Mass Index (BMI) between 19 to 25kg/㎡ (19kg/㎡ ≤ BMI < 25kg/㎡) and weight at least 50kg on the day of screening
- •Medically healthy with no clinically significant findings on vital signs during the screening period
- •Medically healthy with no clinically significant findings on physical examinations during the screening period
排除标准
- •Subjects with clinically significant medical or surgical history described below Clinically significant observations considered as unsuitable based on medical judgement by investigators
- •Skin disorder (psoriasis or contact dermatitis) which may affect absorption of the investigational product, or scar, skin abnormality, history of surgery (excluding simple appendectomy or herniorrhaphy) which can interrupt intradermal injections
- •History of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, respiratory, musculoskeletal or any other conditions which can be problems for pharmacokinetic evaluation
- •Donated blood or blood components or had been transfused plasma within 60 days prior to the day of screening
- •Tobacco use within 30 days prior to the day of screening
研究组 & 干预措施
BMT101
Experimental
cp-lasiRNA
干预措施: BMT101 (Drug)
Placebo
Placebo Comparator
Normal Saline
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
时间窗: 14 days
Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
次要结局
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½(4 days)
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC(4 days)
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax(4 days)
研究者
研究点 (1)
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