A Randomized, Double-Blind, Single-Center, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of Intravenous DTRI-031 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Safety as assessed by adverse events (AEs)
研究概览
简要总结
A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031
详细描述
Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort.
Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28.
A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.
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
- Double (Participant, Investigator)
盲法说明
Double blinded, placebo-controlled
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 50-110 kg with BMI 18.5-32 kg/m2
- •Willingness to use contraceptives
- •Negative COVID-19 test
- •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 clinical 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 3 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
Active Comparator: Single ascending dose DTRI-031
Drug: DTRI-031 Single doses of DTRI-031 delivered via intravenous injection. Ascending dose levels will be evaluated.
干预措施: DTRI-031 (Drug)
Placebo Comparator: Single Dose Placebo
Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as assessed by adverse events (AEs)
时间窗: From dosing (DTRI-031 or placebo) to final visit (Day 28)
Incidence of treatment-emergent AEs
次要结局
- Platelet Function(From dosing to 24 hours after dosing)
- Plasma von Willebrand Factor (vWF) levels(From dosing to 24 hours after dosing)
- Pharmacokinetics as measured by DTRI-031 plasma levels(From dosing to 24 hours after dosing)