A Single Center, Two-part, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BB-025 or Placebo, Alone and Following a Single Dose of BB-031, in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety as assessed by adverse events (AEs)
研究概览
简要总结
The goal of this 2-part clinical trial is to learn about the safety and pharmacokinetics (PK) of a single dose of BB-025 when given on its own and after being given BB-031. Researchers will compare BB-025 to placebo (a look-alike substance that contains no drug) both on its own and after being given a single dose of BB-031 to assess the use of BB-025 as a reversal agent.
In the first part of the study, participants will receive a single dose of BB-025 or placebo. They will be followed for 28 days to check if they have any symptoms.
In the second part of the study, participants will receive a single dose of BB-031 and then be given either BB-025 or placebo. These participants will also be followed for 28 days to check if they have any symptoms.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years of age
- •Ability to provide written consent
- •Weight 50-100 kg with BMI 18-32 kg/m2
- •Willingness to use contraceptives
- •Negative results for alcohol and drugs of abuse
排除标准
- •Pregnant or lactating females
- •Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
- •Females with active menstruation on day of dosing
- •Use of prescription medications known to affect platelet function
- •Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
- •Contraindication to anticoagulation or increased bleeding risks
- •History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
- •History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
- •Planned surgery during the study
- •Any clinically significant abnormality at screening
- •Use of investigational drug in past 30 days or 5 half lives
- •Concurrent enrollment in another clinical study or more than 4 clinical studies in past 12 months
- •Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test
研究组 & 干预措施
Single Dose BB-031
Drug: BB-031, Investigational Drug
干预措施: BB-031 (Drug)
Single Dose Placebo
Drug: Matched placebo to BB-025 cohorts
干预措施: BB-025 (Drug)
Single Ascending Dose BB-025
Drug: BB-025, Investigational Drug
干预措施: BB-025 (Drug)
结局指标
主要结局
Safety as assessed by adverse events (AEs)
时间窗: From dosing of study drug to final visit (Day 28)
Incidence of treatment-emergent AEs
次要结局
- Pharmacokinetics as measured by BB-025 plasma levels(From dosing to 24 hours after dosing)
- Pharmacokinetics as measured by BB-031 plasma levels(From dosing to 24 hours after dosing)
- Pharmacokinetics as measured by BB-025/BB-031 Complex plasma levels(From dosing of BB-031 through 24 hours after dosing of BB-025)
- Plasma von Willebrand Factor (vWF) Levels(From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025)
- Platelet Function(From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing)