A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
详细描述
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent and be able to comply with all study requirements
- •Males or females aged 18 to 65 years old, inclusive, at the time of informed consent
- •Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
- •APTT, PT, INR, and FXI activity within the normal range at screening
- •Agree to avoid activities that can increase the risk of severe bleeding
- •Female participants must be non-pregnant
- •Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 360 days following administration of the study drug
排除标准
- •Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
- •Any skin condition and/or tattoo
- •Hospitalization for any reason within 60 days prior to screening
- •History or presence of cancer
- •Any clinically significant acute condition
- •Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
- •Clinical laboratory findings outside of range
- •Any liver function panel analyte value > 1.2 × upper limits of normal (ULN)
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
- •Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
- •Use of an investigational agent
- •.Used of prescription drugs
- •History or clinical evidence of alcohol substance abuse
- •History or clinical evidence of drug abuse
- •Positive test for alcohol or drugs of abuse at screening or Day -1
- •Donated or lost >200 mL of blood
- •.Any conditions which, in the opinion of the Investigator
研究组 & 干预措施
Cohort 1
BW-41012 (cohort 1, n=8)
干预措施: BW-41012 injection or Placebo (Drug)
Cohort 2
BW-41012 (cohort 2, n=8)
干预措施: BW-41012 injection or Placebo (Drug)
Cohort 3
BW-41012 (cohort 3, n=8)
干预措施: BW-41012 injection or Placebo (Drug)
Cohort 4
BW-41012 (cohort 4, n=8)
干预措施: BW-41012 injection or Placebo (Drug)
Cohort 5
BW-41012 (cohort 5, n=8)
干预措施: BW-41012 injection or Placebo (Drug)