A First-in-human, Randomized, Double-blind, Parallel, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 12-lead electrocardiogram (ECG)
研究概览
简要总结
To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
B1344/Placebo:2mg.
干预措施: B1344 (Drug)
Cohort 1
B1344/Placebo:2mg.
干预措施: Placebo (Other)
Cohort 2
B1344/Placebo:5mg.
干预措施: B1344 (Drug)
Cohort 2
B1344/Placebo:5mg.
干预措施: Placebo (Other)
Cohort 3
B1344/Placebo:15mg.
干预措施: B1344 (Drug)
Cohort 3
B1344/Placebo:15mg.
干预措施: Placebo (Other)
Cohort 4
B1344/Placebo:30mg.
干预措施: B1344 (Drug)
Cohort 4
B1344/Placebo:30mg.
干预措施: Placebo (Other)
Cohort 5
B1344/Placebo:45mg.
干预措施: B1344 (Drug)
Cohort 5
B1344/Placebo:45mg.
干预措施: Placebo (Other)
Cohort 6
B1344/Placebo:60mg.
干预措施: B1344 (Drug)
Cohort 6
B1344/Placebo:60mg.
干预措施: Placebo (Other)
Cohort 7
B1344/Placebo:80mg.
干预措施: B1344 (Drug)
Cohort 7
B1344/Placebo:80mg.
干预措施: Placebo (Other)
结局指标
主要结局
12-lead electrocardiogram (ECG)
时间窗: From the screening period to 29 days after administration
Changes of 12-lead ECG from baseline
Physical examinations
时间窗: From the screening period to 90 days after administration
Number of participants with abnormal Physical examinations.
Injection site reactions assessments
时间窗: Within 3 days of administration
The injection site reaction assessment will be done by the PI/investigational staff and study subject using the criteria, which consist of rating the severity of redness, swelling, skin temperature, sensitivity and pain at the injection site.
Renal Ultrasonography
时间窗: From the screening period to 29 days after administration
The examination of both kidneys using medical ultrasonography will be performed to detect any harmful abscesses, fluid collection, and infection within or around the kidneys.
Anti-Drug Antibody(ADA)
时间窗: Within 29 days of administration
he incidence and proportion of ADA positive subjects.
次要结局
未报告次要终点