A Phase 1a/1b Study of OPT101 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
详细描述
2 part study description:
• an initial Phase 1a single ascending dose (SAD) phase to identify a safe dose of OPT101.
Dose escalation will be by a factor of 2.6: 0.16, 0.42, 1.1, 2.8 and 7.3mg/kg.
• a Phase 1b multiple ascending dose (MAD) phase to measure safety and clinical effects of the highest and next to highest dose of OPT101 that are found to be safe in Phase 1a.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Pharmacist will be the only unmasked clinical staff as the preparer of the investigational product prior to infusion.
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
0.9% Sodium Chloride Injection USP
Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes.
干预措施: OPT101 (Drug)
OPT101
The starting dose for the Phase 1a study is 0.16 mg/kg, which is 35-fold lower than the dog NOAEL (10mg/kg), on a mg/m2 basis. The dosing frequency for the MAD study was selected based on dosing performed in the supporting animal model studies. For an additional safety factor, the dose and volume infusion rates for the 0.16 mg/kg dose in humans will be 67-fold and 14-fold lower than the dogs dosed at 10mg/kg/min and mL/kg/min basis, respectively. For both Phase 1a and 1b, OPT101 will be administered by a slow IV infusion over 30 minutes.
干预措施: OPT101 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: 21 days
Incidence of abnormal vital signs and abnormal laboratory values
Incidence of vital signs
时间窗: 48 hours
Continuous telemetry monitoring
Incidence of abnormal laboratory values
时间窗: 21 days
Blood laboratory results and iStat results onsite
Rate and type of adverse events during and after infusion of OPT101 or placebo
时间窗: 48 hours
Collection of all adverse events
Definition of maximum tolerated (MTD) single and repeated doses of OPT101
时间窗: 48 hours
DMC and Safety and Tolerability
次要结局
- Development of anti-drug antibodies after 1 or more infusions(2 weeks- 1 prior to infusion and day 15)
- Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)(8 hours)